azathioprine

Generic: azathioprine

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azathioprine
Generic Name azathioprine
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

azathioprine 50 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-835
Product ID 16571-835_99588075-8b4a-45ec-90ca-2a23fdd8262a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075568
Listing Expiration 2026-12-31
Marketing Start 2024-06-06

Pharmacologic Class

Established (EPC)
purine antimetabolite [epc]
Mechanism of Action
nucleic acid synthesis inhibitors [moa]
Chemical Structure
nucleosides [cs] purines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571835
Hyphenated Format 16571-835

Supplemental Identifiers

RxCUI
197388
UNII
MRK240IY2L
NUI
N0000000233 M0015066 N0000175712 M0018169

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name azathioprine (source: ndc)
Generic Name azathioprine (source: ndc)
Application Number ANDA075568 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16571-835-01)
source: ndc

Packages (1)

16571-835-01 100 TABLET in 1 BOTTLE (16571-835-01)

Ingredients (1)

azathioprine (50 mg/1)

Linked Drug Pages (1)

AZATHIOPRINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "99588075-8b4a-45ec-90ca-2a23fdd8262a", "openfda": {"nui": ["N0000000233", "M0015066", "N0000175712", "M0018169"], "unii": ["MRK240IY2L"], "rxcui": ["197388"], "spl_set_id": ["2ffa2fce-895d-469e-8667-b078560aec5f"], "pharm_class_cs": ["Nucleosides [CS]", "Purines [CS]"], "pharm_class_epc": ["Purine Antimetabolite [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16571-835-01)", "package_ndc": "16571-835-01", "marketing_start_date": "20240606"}], "brand_name": "AZATHIOPRINE", "product_id": "16571-835_99588075-8b4a-45ec-90ca-2a23fdd8262a", "dosage_form": "TABLET", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleosides [CS]", "Purine Antimetabolite [EPC]", "Purines [CS]"], "product_ndc": "16571-835", "generic_name": "Azathioprine", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AZATHIOPRINE", "active_ingredients": [{"name": "AZATHIOPRINE", "strength": "50 mg/1"}], "application_number": "ANDA075568", "marketing_category": "ANDA", "marketing_start_date": "20240606", "listing_expiration_date": "20261231"}