Home NDC 67457-618 Gemcitabine
Product NDC 67457-618
11-digit product format 674570618
Labeler code 67457
Product ID 67457-618_93d514c4-a877-475d-91e0-9cfb232d55ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name GEMCITABINE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA205242
Marketing category ANDA
Marketing start 2017-12-18
Substance GEMCITABINE HYDROCHLORIDE
Active strength 2 g/52.6mL
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A205242-001 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 A205242-002 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 A205242-003 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06
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 · 129 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 2026-09-14 22:38:34 2026-08 A205242-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205242-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205242-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205242-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205242-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205242-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205242-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205242-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205242-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205242-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205242-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205242-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205242-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205242-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205242-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205242-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205242-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205242-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205242-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205242-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205242-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205242-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205242-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205242-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205242-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205242-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205242-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205242-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205242-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205242-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205242-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205242-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205242-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205242-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205242-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205242-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205242-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205242-002 GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205242-003 GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205242-001 GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE / INJECTION AP 2017-12-06 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Gemcitabine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GEMCITABINE HYDROCHLORIDE 2 g/52.6mL
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 67457-618-10 Gemcitabine 1 in 1 CARTON INJECTION, SOLUTION 1 6 67457-618-10 Gemcitabine 52.6 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 52.6 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-618 GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241127_06dd9d40-74fc-4409-93b1-a46be7126331.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 Marketing start Marketing end Sample Exclude flag Status 67457-618-10 67457061810 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-618-10) / 52.6 mL in 1 VIAL, SINGLE-DOSE 2017-12-18 0000-00-00 No No Current