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 firm2026-08-17
excluded packagepackage68001-35068001-350-68DDiscontinued by firm2026-08-17

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 42.

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209604-001GEMCITABINE HYDROCHLORIDE200MG/2ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209604-002GEMCITABINE HYDROCHLORIDE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209604-003GEMCITABINE HYDROCHLORIDE1.5GM/15ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209604-004GEMCITABINE HYDROCHLORIDE2GM/20ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-08-03d8e5a09893c0…

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

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GEMCITABINEGEMCITABINEBluePoint Laboratories4031017d-d768-46de-8081-476bcb883f5e2023-09-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 209604
application number: NDA209604
ndc (product): 68001-350

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