Home NDC 0002-7501 Gemzar
Product NDC 0002-7501
11-digit product format 000027501
Labeler code 0002
Product ID 0002-7501_a15ac76a-1795-4c3e-be36-96b064a58d42
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gemcitabine hydrochloride
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Eli Lilly and Company
Application NDA020509
Marketing category NDA
Marketing start 1996-05-15
Marketing end 2021-05-31
Substance GEMCITABINE HYDROCHLORIDE
Active strength 200 mg/5mL
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0002-7501-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0002-7501-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0002-7501-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0002-7501-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0002-7501-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0002-7501-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0002-7501-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0002-7501-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0002-7501-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0002-7501-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0002-7501-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0002-7501-01 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N020509-001 GEMZAR GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 N020509-002 GEMZAR GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15
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 · 84 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 2026-08-18 06:07:40 2026-07 N020509-001 GEMZAR EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020509-002 GEMZAR EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020509-001 GEMZAR EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020509-002 GEMZAR EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020509-001 GEMZAR EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020509-002 GEMZAR EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020509-001 GEMZAR EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020509-002 GEMZAR EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020509-001 GEMZAR EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020509-002 GEMZAR EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020509-001 GEMZAR EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020509-002 GEMZAR EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020509-001 GEMZAR EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020509-002 GEMZAR EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020509-001 GEMZAR EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020509-002 GEMZAR EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020509-001 GEMZAR EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020509-002 GEMZAR EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020509-001 GEMZAR EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020509-002 GEMZAR EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020509-001 GEMZAR EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020509-002 GEMZAR EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020509-001 GEMZAR EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020509-002 GEMZAR EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020509-001 GEMZAR EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020509-002 GEMZAR EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020509-001 GEMZAR EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020509-002 GEMZAR EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020509-001 GEMZAR EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020509-002 GEMZAR EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020509-001 GEMZAR EQ 200MG BASE/VIAL INJECTABLE / INJECTION RLD 1996-05-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020509-002 GEMZAR EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1996-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020509-001 GEMZAR EQ 200MG BASE/VIAL INJECTABLE / INJECTION RLD 1996-05-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020509-002 GEMZAR EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1996-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020509-001 GEMZAR EQ 200MG BASE/VIAL INJECTABLE / INJECTION RLD 1996-05-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020509-002 GEMZAR EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1996-05-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020509-001 GEMZAR EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020509-002 GEMZAR EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020509-001 GEMZAR EQ 200MG BASE/VIAL INJECTABLE / INJECTION RLD 1996-05-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020509-002 GEMZAR EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1996-05-15 bb7c543d1eb4…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Gemcitabine hydrochloride ACTIVE INGREDIENT U347PV74IL GEMZAR (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ELI LILLY AND COMPANY
] 18 Gemcitabine ACTIVE MOIETY B76N6SBZ8R GEMZAR (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ELI LILLY AND COMPANY
] 18 Hydrochloric acid INACTIVE INGREDIENT QTT17582CB GEMZAR (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ELI LILLY AND COMPANY
] 18 Mannitol INACTIVE INGREDIENT 3OWL53L36A GEMZAR (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ELI LILLY AND COMPANY
] 18 Sodium acetate INACTIVE INGREDIENT 4550K0SC9B GEMZAR (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ELI LILLY AND COMPANY
] 18 Sodium hydroxide INACTIVE INGREDIENT 55X04QC32I GEMZAR (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ELI LILLY AND COMPANY
] 18