What is NDC 68382-120?

68382-120 is the product NDC for Azathioprine, Azathioprine 100 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 68382-120 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-120Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0120Add 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
68382-120-01	6838201200168382012001	100 TABLET in 1 BOTTLE (68382-120-01)Marketed from Dec 2, 2017
68382-120-05	6838201200568382012005	500 TABLET in 1 BOTTLE (68382-120-05)Marketed from Dec 2, 2017

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: Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077621
Marketing start: Dec 2, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)Nucleosides (Chemical structure)Purines (Chemical structure)
Identifiers: Product ID 68382-120_64e1751f-fdf5-45e7-ac57-6499c0b5aa91SPL ID 64e1751f-fdf5-45e7-ac57-6499c0b5aa91SPL set ID b1b0fa3e-11c3-46d0-9537-6b372c2a1b56RxCUI 197388, 199310, 359228, 359229UNII 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

N468382012001 followed by a unit qualifier and the quantity

Package 68382-0120-01. 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 Aug 2, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Azathioprine tablets, USP 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, USP 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-120

What is NDC 68382-120?: 68382-120 is the product NDC for Azathioprine, Azathioprine 100 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 2 package NDCs, 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?: Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 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

All 29 Azathioprine NDCs

Other NDCs under ANDA 077621

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

FDA NDC Directory listings under ANDA 077621
Product	Strength	Form · route	Labeler	Product NDC
Azathioprine	Azathioprine 50 mg/1	TabletOral	Zydus Lifesciences Limited	65841-602
Azathioprine	Azathioprine 50 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3772
Azathioprine	Azathioprine 50 mg/1	TabletOral	American Health Packaging	68084-229
Azathioprine	Azathioprine 50 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-003
Azathioprine	Azathioprine 25 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-118
Azathioprine	Azathioprine 75 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-119
Azathioprine	Azathioprine 25 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1139
Azathioprine	Azathioprine 75 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1140
Azathioprine	Azathioprine 100 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1141