Packaging and Labeling: How to Identify Authorized Generics

When you pick up a prescription, you might not notice the difference between a brand-name pill and a generic one. But there’s a hidden category that’s neither fully brand nor fully generic - the authorized generic. These are the exact same drug as the brand-name version, made in the same factory, with the same ingredients, same strength, and same effect. The only difference? The box and the label. And if you don’t know how to spot them, you could miss out on savings - or worse, get confused when your medication looks different.

What Makes an Authorized Generic Different?

Authorized generics aren’t just another type of generic drug. They’re the original brand-name drug, sold under a different label. The company that made the brand-name drug - say, Pfizer for Lyrica - also makes the authorized generic, often through a subsidiary like Greenstone LLC. It’s the same capsule, same powder, same machine that filled it. The FDA calls this a "listed drug" marketed under the original New Drug Application (NDA), not the Abbreviated New Drug Application (ANDA) that traditional generics use.

That’s why authorized generics are identical in every way to the brand. No bioequivalence studies needed. No guesswork. If the brand works for you, the authorized generic will too. The only changes are on the outside: the name on the label, the company listed as the distributor, and sometimes the color or imprint on the pill.

How to Spot an Authorized Generic by the Label

Start by looking at the packaging. Brand-name drugs usually have flashy logos, trademarks, and marketing claims like "Clinically Proven" or "Trusted by Millions." Authorized generics don’t. Their labels are plain. No trademarks. No slogans. Just the drug name, strength, and manufacturer info.

Check the manufacturer or distributor line. If it says "Distributed by Greenstone LLC" instead of "Manufactured by Pfizer," that’s a strong sign. The actual manufacturing facility is almost always the same as the brand’s. You’ll see the same facility number on the label, just under a different company name.

Also look for the absence of the brand name. If the box says "Omeprazole" instead of "Prilosec," and you know Prilosec is the brand, you’re likely looking at an authorized generic. The drug name is the same, but the brand name is gone.

The NDC Code: Your Most Reliable Tool

Every drug package has a National Drug Code (NDC), a 10- or 11-digit number usually printed on the label. It’s broken into three parts: labeler code, product code, and package code.

For an authorized generic:

• The labeler code (first part) will be different from the brand’s. For example, Prilosec’s labeler code is 00071 (AstraZeneca). The authorized generic uses 55111 (AstraZeneca’s subsidiary).
• The product code (second part) and package code (third part) stay exactly the same.

That’s the golden rule. If the last two parts match the brand’s NDC, but the first part is different, it’s an authorized generic. Traditional generics have completely different NDCs across all three segments.

You can verify this by checking the FDA’s Quarterly Authorized Generic List. Updated every January, April, July, and October, it lists every authorized generic currently on the market. If your drug’s NDC is there - and the labeler code matches - you’ve confirmed it.

Why the Packaging Looks Different

You might notice the pills themselves look different. A blue Lyrica capsule from Pfizer might be white with a different imprint in the authorized version. That’s not a mistake. U.S. trademark law prevents generic drugs from looking identical to branded ones, even if they’re the same medicine. So manufacturers change the color, shape, or imprint slightly - but the active ingredient remains unchanged.

Some authorized generics even have small "AG" or "Authorized Generic" printed in tiny letters on the label. It’s not required by the FDA, but some companies do it to help pharmacists and patients. Don’t rely on that though - many don’t use it at all.

Authorized Generics vs. Traditional Generics

It’s easy to confuse the two. Here’s how they differ:

Comparison: Authorized Generics vs. Traditional Generics

Feature	Authorized Generic	Traditional Generic
Manufacturer	Same as brand-name company	Separate generic manufacturer
Active Ingredients	Identical to brand	Identical to brand
Inactive Ingredients	Identical to brand	May differ
NDC Code	Same product & package code; different labeler code	Completely different NDC
Approved Through	Original NDA	Abbreviated New Drug Application (ANDA)
Labeling	Same as brand, minus trademarks	May differ slightly; includes bioequivalence statement
Price	15-25% below brand, 5-15% above traditional generic	Lowest price option

Common Mistakes and How to Avoid Them

Pharmacists and patients often misidentify authorized generics. A 2021 survey found nearly 37% of pharmacists confused them with traditional generics. Why? Because the packaging looks similar.

Here are the top errors:

• Thinking different pill color = different drug. It’s not. The active ingredient is unchanged.
• Assuming a new manufacturer means it’s not the same. The same factory can produce both brand and authorized generic under different labels.
• Ignoring the NDC. If you don’t check the labeler code, you’ll miss the key identifier.
• Confusing "authorized generic" with "authorized brand." Some companies sell traditional generics in brand-like packaging - these are not authorized generics.

The best way to avoid mistakes? Always check the NDC against the FDA’s list. If your pharmacy’s system doesn’t flag it, ask them to verify. Most modern pharmacy databases - like First Databank and Medi-Span - now include authorized generic markers, but not all do.

Why It Matters for Patients

If you’re paying out-of-pocket, authorized generics can save you money without sacrificing quality. They’re cheaper than the brand, but just as reliable. Many patients report no difference in how they feel - 92.6% in a 2022 Medscape survey said their experience was identical to the brand.

But confusion can cause anxiety. Some patients worry when the pill looks different or the label says a company they’ve never heard of. That’s normal. The drug is still the same. The FDA inspects the manufacturing sites just like the brand. There’s no drop in quality.

If you’re unsure, ask your pharmacist: "Is this an authorized generic?" They can pull up the NDC and confirm. It’s not a dumb question - it’s smart.

What’s Changing in 2025?

The FDA plans to integrate authorized generic identifiers directly into the National Drug Code Directory by mid-2024. That means pharmacy systems will automatically flag authorized generics - no manual lookup needed. This should cut down on dispensing errors, which currently account for 8.3% of generic drug mistakes, according to the 2022 ISMP report.

Right now, you’re still responsible for checking. But soon, your pharmacy app might show a small badge: "Authorized Generic - Same as Brand." Until then, know your NDC. Know your label. And don’t assume a different-looking pill is a different drug.

How to Verify Your Prescription

Here’s a simple 3-step checklist you can use every time you get a generic prescription:

1. Look at the label. Is the brand name missing? Is there a distributor name like "Greenstone," "Dr. Reddy’s," or "Mylan" instead of the original maker?
2. Find the NDC code. Write it down. Go to the FDA’s Authorized Generic List and search by drug name or NDC.
3. Compare the labeler code. If it’s different from the brand’s but the product and package codes match - you’ve got an authorized generic.

Keep a note of your drug’s NDC on your phone or in your wallet. It takes 30 seconds to check and can save you hundreds a year.