gemcitabine

Generic: gemcitabine hydrochloride

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

Drug Facts

Product Profile

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

gemcitabine hydrochloride 38 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-117
Product ID 71288-117_be3f7738-022f-4b20-94f3-40f5337997c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212129
Listing Expiration 2026-12-31
Marketing Start 2020-12-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288117
Hyphenated Format 71288-117

Supplemental Identifiers

RxCUI
1720960 1720975 1720977
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 ANDA212129 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 38 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-91) / 5.26 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-92) / 26.3 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-93) / 52.6 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (3)

71288-117-91 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-91) / 5.26 mL in 1 VIAL, SINGLE-DOSE 71288-117-92 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-92) / 26.3 mL in 1 VIAL, SINGLE-DOSE 71288-117-93 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-93) / 52.6 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

gemcitabine hydrochloride (38 mg/mL)

Linked Drug Pages (2)

Gemcitabine ndc-match (0.9) Gemcitabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "be3f7738-022f-4b20-94f3-40f5337997c1", "openfda": {"unii": ["U347PV74IL"], "rxcui": ["1720960", "1720975", "1720977"], "spl_set_id": ["c0b1b715-9ff8-43ca-9e49-465f1f380084"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-91)  / 5.26 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-117-91", "marketing_start_date": "20201211"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-92)  / 26.3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-117-92", "marketing_start_date": "20201211"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-93)  / 52.6 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-117-93", "marketing_start_date": "20201211"}], "brand_name": "Gemcitabine", "product_id": "71288-117_be3f7738-022f-4b20-94f3-40f5337997c1", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "71288-117", "generic_name": "Gemcitabine hydrochloride", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gemcitabine", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "38 mg/mL"}], "application_number": "ANDA212129", "marketing_category": "ANDA", "marketing_start_date": "20201211", "listing_expiration_date": "20261231"}