Home NDC 16729-426 GEMCITABINE
Product NDC 16729-426
11-digit product format 167290426
Labeler code 16729
Product ID 16729-426_ecb6a530-5574-6877-e053-2a95a90aa57f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name GEMCITABINE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Accord Healthcare Inc.
Application NDA209604
Marketing category NDA
Marketing start 2018-08-06
Marketing end 0000-00-00
Substance GEMCITABINE HYDROCHLORIDE
Active strength 100 mg/mL
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209604-001 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 200MG/2ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2017-08-03 N209604-002 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2017-08-03 N209604-003 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1.5GM/15ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2017-08-03 N209604-004 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2017-08-03
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 5 · 168 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 N209604-001 GEMCITABINE HYDROCHLORIDE 200MG/2ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2017-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209604-002 GEMCITABINE HYDROCHLORIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2017-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209604-003 GEMCITABINE HYDROCHLORIDE 1.5GM/15ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2017-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209604-004 GEMCITABINE HYDROCHLORIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2017-08-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209604-001 GEMCITABINE HYDROCHLORIDE 200MG/2ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209604-002 GEMCITABINE HYDROCHLORIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209604-003 GEMCITABINE HYDROCHLORIDE 1.5GM/15ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209604-004 GEMCITABINE HYDROCHLORIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209604-001 GEMCITABINE HYDROCHLORIDE 200MG/2ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209604-002 GEMCITABINE HYDROCHLORIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209604-003 GEMCITABINE HYDROCHLORIDE 1.5GM/15ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209604-004 GEMCITABINE HYDROCHLORIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209604-001 GEMCITABINE HYDROCHLORIDE 200MG/2ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209604-002 GEMCITABINE HYDROCHLORIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209604-003 GEMCITABINE HYDROCHLORIDE 1.5GM/15ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209604-004 GEMCITABINE HYDROCHLORIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209604-001 GEMCITABINE HYDROCHLORIDE 200MG/2ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209604-002 GEMCITABINE HYDROCHLORIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209604-003 GEMCITABINE HYDROCHLORIDE 1.5GM/15ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209604-004 GEMCITABINE HYDROCHLORIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209604-001 GEMCITABINE HYDROCHLORIDE 200MG/2ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209604-002 GEMCITABINE HYDROCHLORIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209604-003 GEMCITABINE HYDROCHLORIDE 1.5GM/15ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209604-004 GEMCITABINE HYDROCHLORIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209604-001 GEMCITABINE HYDROCHLORIDE 200MG/2ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209604-002 GEMCITABINE HYDROCHLORIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209604-003 GEMCITABINE HYDROCHLORIDE 1.5GM/15ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209604-004 GEMCITABINE HYDROCHLORIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209604-001 GEMCITABINE HYDROCHLORIDE 200MG/2ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209604-002 GEMCITABINE HYDROCHLORIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209604-003 GEMCITABINE HYDROCHLORIDE 1.5GM/15ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209604-004 GEMCITABINE HYDROCHLORIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209604-001 GEMCITABINE HYDROCHLORIDE 200MG/2ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209604-002 GEMCITABINE HYDROCHLORIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209604-003 GEMCITABINE HYDROCHLORIDE 1.5GM/15ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209604-004 GEMCITABINE HYDROCHLORIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209604-001 GEMCITABINE HYDROCHLORIDE 200MG/2ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209604-002 GEMCITABINE HYDROCHLORIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209604-003 GEMCITABINE HYDROCHLORIDE 1.5GM/15ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209604-004 GEMCITABINE HYDROCHLORIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-08-03 d8e5a09893c0…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-426 GEMCITABINE INJECTION, SOLUTION [ACCORD HEALTHCARE INC.] 8 Legacy NDC 20240926_5a335d36-408b-478f-9563-4bc140b69bb6.zip
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Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16729-426-05 16729042605 20 mL in 1 VIAL, MULTI-DOSE (16729-426-05) 20 ml 2018-08-06 0000-00-00 No No Current