Home NDC 0409-0186 Gemcitabine
Product NDC 0409-0186
11-digit product format 004090186
Labeler code 0409
Product ID 0409-0186_111b13bb-6793-4b33-b845-0dc9b46837de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name GEMCITABINE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA078339
Marketing category ANDA
Marketing start 2011-07-26
Substance GEMCITABINE HYDROCHLORIDE
Active strength 38 mg/mL
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 A078339-001 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 A078339-002 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 A078339-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078339-002 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 A078339-001 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 A078339-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078339-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078339-002 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 A078339-001 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 A078339-002 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 A078339-001 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 A078339-002 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 A078339-001 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 A078339-002 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 A078339-001 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 A078339-002 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 A078339-001 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 A078339-002 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 A078339-001 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 A078339-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078339-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078339-002 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 A078339-001 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 A078339-002 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 A078339-001 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 A078339-002 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 A078339-001 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 A078339-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078339-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078339-002 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 A078339-001 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 A078339-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078339-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078339-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078339-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078339-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078339-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078339-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078339-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078339-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078339-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078339-002 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 38 mg/mL
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 0409-0186-01 Gemcitabine 25 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 25 27 0409-0186-01 Gemcitabine 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GEMCITABINE HYDROCHLORIDE ACTIVE INGREDIENT U347PV74IL GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 16 GEMCITABINE ACTIVE MOIETY B76N6SBZ8R GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 16 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 16 MANNITOL INACTIVE INGREDIENT 3OWL53L36A GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 16 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 16 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-0186 GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 27 Current NDC, Legacy NDC, 2 package rows 20240903_d16907e7-a8c8-4039-ace4-cf4e24ba68c0.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 · 1 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 0409-0186-01 00409018601 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0186-01) / 25 mL in 1 VIAL, SINGLE-DOSE 2011-07-26 0000-00-00 No No Current