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 44 .
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 · 176 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 2026-10-15 13:18:30 2026-09 N209604-001 GEMCITABINE HYDROCHLORIDE 200MG/2ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2017-08-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209604-002 GEMCITABINE HYDROCHLORIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2017-08-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209604-003 GEMCITABINE HYDROCHLORIDE 1.5GM/15ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2017-08-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209604-004 GEMCITABINE HYDROCHLORIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2017-08-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 N209604-001 GEMCITABINE HYDROCHLORIDE 200MG/2ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2017-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209604-002 GEMCITABINE HYDROCHLORIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2017-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209604-003 GEMCITABINE HYDROCHLORIDE 1.5GM/15ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2017-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209604-004 GEMCITABINE HYDROCHLORIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2017-08-03 84e616aacf4f…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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