Home NDC 68001-350 GEMCITABINE
Product NDC 68001-350
11-digit product format 680010350
Labeler code 68001
Product ID 68001-350_830c5aa5-79d2-4342-9d53-070bfd7ab05c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name GEMCITABINE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler BluePoint Laboratories
Application NDA209604
Marketing category NDA
Marketing start 2018-05-25
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 2020-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68001-350-68 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68001-350-68 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68001-350-68 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68001-350-68 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68001-350-68 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68001-350-68 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68001-350-68 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68001-350-68 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68001-350-68 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68001-350-68 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68001-350-68 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68001-350-68 557ba5c1ecfa…9c80585c8c6e…
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68001-350-68 GEMCITABINE 15 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 15 5 68001-350-68 GEMCITABINE 1 in 1 CARTON INJECTION, SOLUTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68001-350 GEMCITABINE INJECTION, SOLUTION [BLUEPOINT LABORATORIES] 5 Legacy NDC, 2 package rows 20230912_4031017d-d768-46de-8081-476bcb883f5e.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 68001-350-68 68001035068 1 VIAL, MULTI-DOSE in 1 CARTON (68001-350-68) > 15 mL in 1 VIAL, MULTI-DOSE 2018-05-25 0000-00-00 No No Current