Home NDC 25021-239-05 Gemcitabine
Product NDC 25021-239
Requested package NDC 25021-239-05
11-digit product format 250210239
Labeler code 25021
Product ID 25021-239_adf9b715-8cef-4a0d-ba30-d948b2b04272
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gemcitabine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA209077
Marketing category ANDA
Marketing start 2019-01-15
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 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 · 10 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 2025-04-01 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…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209077-001 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 A209077-002 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 A209077-003 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 A209077-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209077-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209077-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209077-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209077-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209077-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209077-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209077-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209077-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209077-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209077-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209077-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209077-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209077-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209077-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209077-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209077-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209077-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209077-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209077-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209077-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209077-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209077-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209077-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209077-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209077-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209077-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209077-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209077-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209077-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209077-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209077-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209077-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209077-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209077-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209077-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209077-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209077-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209077-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209077-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2018-07-20 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1720960 Internal RxNorm lookup 1720975 Internal RxNorm lookup 1720977 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 25021-239-05 Gemcitabine 1 in 1 CARTON INJECTION, SOLUTION 1 8 25021-239-05 Gemcitabine 5.26 mL in 1 VIAL INJECTION, SOLUTION 5.26 8 25021-239-26 Gemcitabine 26.3 mL in 1 VIAL INJECTION, SOLUTION 26.3 8 25021-239-26 Gemcitabine 1 in 1 CARTON INJECTION, SOLUTION 1 8 25021-239-52 Gemcitabine 1 in 1 CARTON INJECTION, SOLUTION 1 8 25021-239-52 Gemcitabine 52.6 mL in 1 VIAL INJECTION, SOLUTION 52.6 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-239 GEMCITABINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 8 Current NDC, Legacy NDC, 6 package rows 20250426_22af3507-4b4f-4cad-9d61-89ffc4aabbc7.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 Units Marketing start Marketing end Sample Exclude flag Status 25021-239-05 25021023905 1 VIAL in 1 CARTON (25021-239-05) / 5.26 mL in 1 VIAL 1 vial 2019-01-15 0000-00-00 No No Current