NDC codes

FDA NDC Directory
Product NDC (as listed)70518-3544Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-3544Add 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 NDC11-digit (billing)PackageCopy
70518-3544-070518354400100 POUCH in 1 BOX (70518-3544-0) / 1 TABLET in 1 POUCH (70518-3544-1)Marketed from Sep 30, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208687
Marketing start
Listing expires
Other FDA classes
Nucleic Acid Synthesis Inhibitors (Mechanism)Nucleosides (Chemical structure)Purines (Chemical structure)
Identifiers
Product ID 70518-3544_4f58b212-db57-4132-e063-6394a90a1cdfSPL ID 4f58b212-db57-4132-e063-6394a90a1cdfSPL set ID f251f372-c881-483e-8035-c6a8a6bfb4e8RxCUI 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

N470518354400 followed by a unit qualifier and the quantity

Package 70518-3544-00. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & USAGE Azathioprine is 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 is 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: Azathioprine is indicated …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-3544

What is NDC 70518-3544?
70518-3544 is the product NDC for Azathioprine, Azathioprine 50 mg/1 tablet, listed with the FDA by REMEDYREPACK 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?
REMEDYREPACK INC., NDC labeler code 70518. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AzathioprineAzathioprine 50 mg/1TabletOralRising Pharma Holdings, Inc.16571-83516571-0835-01
AzathioprineAzathioprine 100 mg/1TabletOralAvKARE42291-06342291-0063-01
AzathioprineAzathioprine 75 mg/1TabletOralOceanside Pharmaceuticals68682-23168682-0231-01
AzathioprineAzathioprine 100 mg/1TabletOralOceanside Pharmaceuticals68682-24168682-0241-01
AzathioprineAzathioprine 50 mg/1TabletOralAvKARE42291-07142291-0071-01
AzathioprineAzathioprine 75 mg/1TabletOralAmneal Pharmaceuticals NY LLC60219-203660219-2036-01
AzathioprineAzathioprine 100 mg/1TabletOralAmneal Pharmaceuticals NY LLC60219-203760219-2037-01
AzathioprineAzathioprine 25 mg/1TabletOralAscend Laboratories, LLC67877-49267877-0492-0167877-0492-0567877-0492-10+2 more
AzathioprineAzathioprine 75 mg/1TabletOralAscend Laboratories, LLC67877-49467877-0494-0167877-0494-0567877-0494-10+1 more
AzathioprineAzathioprine 50 mg/1TabletOralAscend Laboratories, LLC67877-49367877-0493-0167877-0493-0567877-0493-10+1 more

All 29 Azathioprine NDCs

Other NDCs under ANDA 208687

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

FDA NDC Directory listings under ANDA 208687
ProductStrengthForm · routeLabelerProduct NDC
AzathioprineAzathioprine 25 mg/1TabletOralAscend Laboratories, LLC67877-492
AzathioprineAzathioprine 75 mg/1TabletOralAscend Laboratories, LLC67877-494
AzathioprineAzathioprine 50 mg/1TabletOralAscend Laboratories, LLC67877-493
AzathioprineAzathioprine 100 mg/1TabletOralAscend Laboratories, LLC67877-495
AzathioprineAzathioprine 50 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3997

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in