Home NDC 71288-113 GEMCITABINE
Product NDC 71288-113
11-digit product format 712880113
Labeler code 71288
Product ID 71288-113_b696b925-51e8-48a8-881e-ae0a0373b3c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name GEMCITABINE HYDROCHLORIDE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA091365
Marketing category ANDA
Marketing start 2018-11-01
Substance GEMCITABINE HYDROCHLORIDE
Active strength 200 mg/1
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091365-001 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 A091365-002 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091365-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091365-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base GEMCITABINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GEMCITABINE HYDROCHLORIDE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U347PV74IL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1719000 Internal RxNorm lookup 1719003 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71288-113-10 GEMCITABINE 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 5 71288-113-10 GEMCITABINE 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-113 GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 2 package rows 20250205_a5949d02-29eb-4626-ad35-b7614bb0fa95.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71288-113-10 71288011310 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-113-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2018-11-01 0000-00-00 No No Current