gemcitabine

Generic: gemcitabine hydrochloride

Labeler: armas pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gemcitabine
Generic Name gemcitabine hydrochloride
Labeler armas pharmaceuticals inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

gemcitabine hydrochloride 200 mg/5.26mL

Manufacturer
Armas Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72485-221
Product ID 72485-221_52a15e83-e33d-42e7-9270-636b5b59d63b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210991
Listing Expiration 2026-12-31
Marketing Start 2020-01-15

Pharmacologic Class

Classes
nucleic acid synthesis inhibitors [moa] nucleoside metabolic inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72485221
Hyphenated Format 72485-221

Supplemental Identifiers

RxCUI
1720977
UPC
0372485221028
UNII
U347PV74IL

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 gemcitabine (source: ndc)
Generic Name gemcitabine hydrochloride (source: ndc)
Application Number ANDA210991 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/5.26mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (72485-221-02) / 5.26 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

72485-221-02 1 VIAL, SINGLE-DOSE in 1 CARTON (72485-221-02) / 5.26 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

gemcitabine hydrochloride (200 mg/5.26mL)

Linked Drug Pages (1)

Gemcitabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "52a15e83-e33d-42e7-9270-636b5b59d63b", "openfda": {"upc": ["0372485221028"], "unii": ["U347PV74IL"], "rxcui": ["1720977"], "spl_set_id": ["57b80f66-208d-4903-9443-e4c9239e3207"], "manufacturer_name": ["Armas Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (72485-221-02)  / 5.26 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "72485-221-02", "marketing_start_date": "20200115"}], "brand_name": "Gemcitabine", "product_id": "72485-221_52a15e83-e33d-42e7-9270-636b5b59d63b", "dosage_form": "INJECTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "72485-221", "generic_name": "GEMCITABINE HYDROCHLORIDE", "labeler_name": "Armas Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gemcitabine", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "200 mg/5.26mL"}], "application_number": "ANDA210991", "marketing_category": "ANDA", "marketing_start_date": "20200115", "listing_expiration_date": "20261231"}