Home NDC 0143-9394-01 Gemcitabine
Product NDC 0143-9394
Requested package NDC 0143-9394-01
11-digit product format 001439394
Labeler code 0143
Product ID 0143-9394_37afef8b-07d8-4857-934a-ddea3296e592
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gemcitabine
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA206617
Marketing category ANDA
Marketing start 2021-06-25
Marketing end 0000-00-00
Substance GEMCITABINE
Active strength 200 mg/1
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0143-9394 0143-9394-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0143-9394 0143-9394-01 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 A206617-001 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION 2021-06-25 A206617-002 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2021-06-25
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 2 · 68 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 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION 2021-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2021-06-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION 2021-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2021-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION 2021-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2021-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION 2021-06-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2021-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206617-001 GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A206617-002 GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2021-06-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 58 observed states.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0143-9394-01 00143939401 1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9394-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2021-06-25 0000-00-00 No No Current