What is NDC 16571-835?

16571-835 is the product NDC for Azathioprine, Azathioprine 50 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 16571. 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 16571-835 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-835Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0835Add 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
16571-835-01	16571083501	100 TABLET in 1 BOTTLE (16571-835-01)Marketed from Jun 6, 2024

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 — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075568
Marketing start: Jun 6, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)Nucleosides (Chemical structure)Purines (Chemical structure)
Identifiers: Product ID 16571-835_99588075-8b4a-45ec-90ca-2a23fdd8262aSPL ID 99588075-8b4a-45ec-90ca-2a23fdd8262aSPL set ID 2ffa2fce-895d-469e-8667-b078560aec5fRxCUI 197388UNII MRK240IY2L
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

N416571083501 followed by a unit qualifier and the quantity

Package 16571-0835-01. 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 Feb 4, 2025. 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 tablets on these variables has not been tested in controlled trials. Rheumatoid Arthritis…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16571-835

What is NDC 16571-835?: 16571-835 is the product NDC for Azathioprine, Azathioprine 50 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, Inc.. 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?: Rising Pharma Holdings, Inc., NDC labeler code 16571. 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 100 mg/1	TabletOral	AvKARE	42291-063	42291-0063-01
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 75 mg/1	TabletOral	Amneal Pharmaceuticals NY LLC	60219-2036	60219-2036-01
Azathioprine	Azathioprine 100 mg/1	TabletOral	Amneal Pharmaceuticals NY LLC	60219-2037	60219-2037-01
Azathioprine	Azathioprine 25 mg/1	TabletOral	Ascend Laboratories, LLC	67877-492	67877-0492-0167877-0492-0567877-0492-10+2 more
Azathioprine	Azathioprine 50 mg/1	TabletOral	Ascend Laboratories, LLC	67877-493	67877-0493-0167877-0493-0567877-0493-10+1 more
Azathioprine	Azathioprine 75 mg/1	TabletOral	Ascend Laboratories, LLC	67877-494	67877-0494-0167877-0494-0567877-0494-10+1 more

All 29 Azathioprine NDCs