Home NDC 69097-313-37 GEMCITABINE HYDROCHLORIDE
Product NDC 69097-313
Requested package NDC 69097-313-37
11-digit product format 690970313
Labeler code 69097
Product ID 69097-313_3a57a223-6d5c-4ca9-b504-01a25e7cee18
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name GEMCITABINE HYDROCHLORIDE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Cipla USA Inc.
Application ANDA078759
Marketing category ANDA
Marketing start 2011-07-25
Marketing end 0000-00-00
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 2021-12-31
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
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 A078759-001 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 A078759-002 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 · 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 A078759-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078759-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078759-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078759-002 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 A078759-001 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 A078759-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078759-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078759-002 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 A078759-001 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 A078759-002 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 A078759-001 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 A078759-002 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 A078759-001 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 A078759-002 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 A078759-001 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 A078759-002 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 A078759-001 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 A078759-002 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 A078759-001 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 A078759-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078759-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078759-002 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 A078759-001 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 A078759-002 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 A078759-001 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 A078759-002 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 A078759-001 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 A078759-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078759-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078759-002 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 A078759-001 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 A078759-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078759-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078759-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078759-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078759-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078759-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078759-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078759-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078759-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-07-25 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-313 GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CIPLA USA INC.] 9 Legacy NDC 20200917_b4e58ed9-edb8-4337-ad0d-29e075e66f1d.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69097-313-37 69097031337 1 VIAL, SINGLE-USE in 1 CARTON (69097-313-37) > 5 mL in 1 VIAL, SINGLE-USE 2011-07-25 0000-00-00 No No Current