What is NDC 42291-063?

42291-063 is the product NDC for Azathioprine, Azathioprine 100 mg/1 tablet, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.

AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Azathioprine?

28 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Azathioprine NDC 42291-063 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-063Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0063Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
42291-063-01	42291006301	100 TABLET in 1 BOTTLE (42291-063-01)Marketed from Apr 13, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Azathioprine
Generic name (nonproprietary): azathioprine
Active ingredients: Azathioprine — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: AvKARENDC labeler code 42291
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074069
Marketing start: Apr 13, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)Nucleosides (Chemical structure)Purines (Chemical structure)
Identifiers: Product ID 42291-063_485b4c20-1aeb-8ffd-e063-6294a90a104fSPL ID 485b4c20-1aeb-8ffd-e063-6294a90a104fSPL set ID f93d9408-7b3f-b423-e053-6294a90a31ecRxCUI 359228UNII MRK240IY2LUPC 0342291063013
Pharmacologic class: Purine Antimetabolite

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N442291006301 followed by a unit qualifier and the quantity

Package 42291-0063-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 14, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Azathioprine tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Renal Homotransplantation: Azathioprine tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of azathioprine on these variables has not been tested in controlled trials. Rheumatoid Arthritis: Azathi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42291-063

What is NDC 42291-063?: 42291-063 is the product NDC for Azathioprine, Azathioprine 100 mg/1 tablet, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Azathioprine.
What is the active ingredient?: Azathioprine.
Who is the labeler?: AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Azathioprine?: 28 other product NDCs are listed under this name. See all Azathioprine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Azathioprine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Azathioprine	Azathioprine 50 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-835	16571-0835-01
Azathioprine	Azathioprine 75 mg/1	TabletOral	Oceanside Pharmaceuticals	68682-231	68682-0231-01
Azathioprine	Azathioprine 100 mg/1	TabletOral	Oceanside Pharmaceuticals	68682-241	68682-0241-01
Azathioprine	Azathioprine 50 mg/1	TabletOral	REMEDYREPACK INC.	70518-3544	70518-3544-00
Azathioprine	Azathioprine 50 mg/1	TabletOral	AvKARE	42291-071	42291-0071-01
Azathioprine	Azathioprine 100 mg/1	TabletOral	Amneal Pharmaceuticals NY LLC	60219-2037	60219-2037-01
Azathioprine	Azathioprine 75 mg/1	TabletOral	Amneal Pharmaceuticals NY LLC	60219-2036	60219-2036-01
Azathioprine	Azathioprine 50 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3997	68071-3997-06
Azathioprine	Azathioprine 100 mg/1	TabletOral	Ascend Laboratories, LLC	67877-495	67877-0495-0167877-0495-0567877-0495-10+1 more
Azathioprine	Azathioprine 25 mg/1	TabletOral	Ascend Laboratories, LLC	67877-492	67877-0492-0167877-0492-0567877-0492-10+2 more

All 29 Azathioprine NDCs

Other NDCs under ANDA 074069

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 074069
Product	Strength	Form · route	Labeler	Product NDC
Azathioprine	Azathioprine 100 mg/1	TabletOral	Amneal Pharmaceuticals NY LLC	60219-2037
Azathioprine	Azathioprine 75 mg/1	TabletOral	Amneal Pharmaceuticals NY LLC	60219-2036
Azathioprine	Azathioprine 50 mg/1	TabletOral	Amneal Pharmaceuticals NY LLC	69238-1076
Azathioprine	Azathioprine 50 mg/1	TabletOral	AvKARE	42291-071
Azathioprine	Azathioprine 50 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-124
Azathioprine	Azathioprine 50 mg/1	TabletOral	Amneal Pharmaceuticals NY LLC	60219-1076
Azathioprine	Azathioprine 50 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-129