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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68001-350DDiscontinued by firm2026-10-23
excluded packagepackage68001-35068001-350-68DDiscontinued by firm2026-10-23

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68001-350-68d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68001-350-68f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68001-350-682ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68001-350-68a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68001-350-68cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68001-350-68cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68001-350-68302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68001-350-68ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68001-350-680efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68001-350-68ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68001-350-68367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68001-350-68557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209604-001GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-03
N209604-002GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-03
N209604-003GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-03
N209604-004GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-03

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-03c2088c7a36db…
2026-10-15 13:18:302026-09N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-03c2088c7a36db…
2026-10-15 13:18:302026-09N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-03c2088c7a36db…
2026-10-15 13:18:302026-09N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-03c2088c7a36db…
2026-09-14 22:38:342026-08N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-0384e616aacf4f…
2026-09-14 22:38:342026-08N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-0384e616aacf4f…
2026-09-14 22:38:342026-08N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-0384e616aacf4f…
2026-09-14 22:38:342026-08N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-0384e616aacf4f…
2026-08-18 06:07:402026-07N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-03caaa826d4ba7…
2026-08-18 06:07:402026-07N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-03caaa826d4ba7…
2026-08-18 06:07:402026-07N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-03caaa826d4ba7…
2026-08-18 06:07:402026-07N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2017-08-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-032680178bc6a6…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a2b7d477-0e35-4772-8a9d-99c71e3e210bProduct name220190614
4c31c9b8-06d5-4f83-9eb7-cd946af7067aProduct name520190612
a12a1c0c-65f2-45a0-8bf0-7dfc55c750b6Product name120180829
d2980057-8cff-4896-979e-b4c394974cfdProduct name120170829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-350-68GEMCITABINE15 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION155
68001-350-68GEMCITABINE1 in 1 CARTONINJECTION, SOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-350GEMCITABINE INJECTION, SOLUTION [BLUEPOINT LABORATORIES]5Legacy NDC, 2 package rows20230912_4031017d-d768-46de-8081-476bcb883f5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1998783gemcitabine 100 MG/mL Injectable SolutionPSN4031017d-d768-46de-8081-476bcb883f5e5
1998783gemcitabine 100 MG/ML Injectable SolutionSCD4031017d-d768-46de-8081-476bcb883f5e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-350-68680010350681 VIAL, MULTI-DOSE in 1 CARTON (68001-350-68) > 15 mL in 1 VIAL, MULTI-DOSE2018-05-250000-00-00NoNoCurrent