FDA.reportPublic FDA data

GEMCITABINE

Product NDC
16729-423
11-digit product format
167290423
Labeler code
16729
Product ID
16729-423_ecb6a530-5574-6877-e053-2a95a90aa57f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GEMCITABINE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Accord Healthcare Inc.
Application
NDA209604
Marketing category
NDA
Marketing start
2018-01-24
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
2023-12-31
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 productproduct16729-423DDiscontinued by firm2026-10-23
excluded packagepackage16729-42316729-423-33DDiscontinued by firm2026-10-23

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-423-33ML - Milliliter16729-423db862a3b-772b-4cc4-b1a3-609bc20ea60d12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-423GEMCITABINE INJECTION, SOLUTION [ACCORD HEALTHCARE INC.]8Legacy NDC20240926_5a335d36-408b-478f-9563-4bc140b69bb6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-423-331672904233315 mL in 1 VIAL, MULTI-DOSE (16729-423-33) 15 ml2018-01-240000-00-00NoNoCurrent