NDC codes

FDA NDC Directory
Product NDC (as listed)65649-231Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65649-0231Add 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
65649-231-4165649023141100 TABLET in 1 BOTTLE (65649-231-41)Marketed from Apr 1, 2003

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)
Azasan
Generic name (nonproprietary)
azathioprine
Active ingredients
Azathioprine — 75 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075252
Marketing start
Listing expires
Other FDA classes
Nucleic Acid Synthesis Inhibitors (Mechanism)Nucleosides (Chemical structure)Purines (Chemical structure)
Identifiers
Product ID 65649-231_85aaaf8a-26bf-4878-9356-490f17fe65efSPL ID 85aaaf8a-26bf-4878-9356-490f17fe65efSPL set ID 9050af7a-19c6-4670-937a-9445605de995RxCUI 359228, 359229, 404475, 404476UNII MRK240IY2LUPC 0365649231414
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

N465649023141 followed by a unit qualifier and the quantity

Package 65649-0231-41. 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 AND USAGE: AZASAN 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: AZASAN 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 AZASAN on these variables has not been tested in controlled trials. Rheumatoid Arthritis: AZASAN is indicated for the treatment of …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075252

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

FDA NDC Directory listings under ANDA 075252
ProductStrengthForm · routeLabelerProduct NDC
AzathioprineAzathioprine 50 mg/1TabletOralGlenmark Pharmaceuticals, Inc68462-502
AzathioprineAzathioprine 50 mg/1TabletOralGolden State Medical Supply, Inc.51407-182
AzasanazathioprineAzathioprine 100 mg/1TabletOralSalix Pharmaceuticals65649-241
AzathioprineAzathioprine 75 mg/1TabletOralOceanside Pharmaceuticals68682-231
AzathioprineAzathioprine 100 mg/1TabletOralOceanside Pharmaceuticals68682-241

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