GEMCITABINE
- Product NDC
- 16729-426
- 11-digit product format
- 167290426
- Labeler code
- 16729
- Product ID
- 16729-426_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
- 2018-08-06
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 16729-426 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 16729-426 | 16729-426-05 | D | Discontinued by firm | 2026-10-05 |
Orange Book products#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | |
| 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… |
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 | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16729-426-05 | ML - Milliliter | 16729-426 | 6bc6f53e-9198-419e-a1f2-be79845798eb | 1 | 2018-02-20 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| GEMCITABINE | GEMCITABINE | BluePoint Laboratories | 4031017d-d768-46de-8081-476bcb883f5e | 2023-09-11 | Warnings, Adverse reactions | 209604 NDA209604 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 16729-426-05 | 16729042605 | 20 mL in 1 VIAL, MULTI-DOSE (16729-426-05) | 20 ml | 2018-08-06 | 0000-00-00 | No | No | Current |