GEMCITABINE
- Product NDC
- 50742-497
- Requested package NDC
- 50742-497-53
- 11-digit product format
- 507420497
- Labeler code
- 50742
- Product ID
- 50742-497_cbc8b03c-7da2-4b8f-96ec-2862a224f434
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gemcitabine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Ingenus Pharmaceuticals, LLC
- Application
- ANDA210383
- Marketing category
- ANDA
- Marketing start
- 2019-02-26
- Marketing end
- 0000-00-00
- Substance
- GEMCITABINE HYDROCHLORIDE
- Active strength
- 38 mg/mL
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 package | package | 50742-497 | 50742-497-53 | D | Discontinued by firm | 2026-08-17 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210383-001 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE / INJECTION | 2019-02-14 | ||
| A210383-002 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE / INJECTION | 2019-02-14 | ||
| A210383-003 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE / INJECTION | 2019-02-14 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A210383-001 | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE / INJECTION | 2019-02-14 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210383-002 | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE / INJECTION | 2019-02-14 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210383-003 | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE / INJECTION | 2019-02-14 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210383-001 | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210383-002 | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210383-003 | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210383-001 | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210383-002 | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210383-003 | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210383-001 | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210383-002 | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210383-003 | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210383-001 | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210383-002 | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210383-003 | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210383-001 | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210383-002 | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210383-003 | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210383-001 | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210383-002 | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210383-003 | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210383-001 | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210383-002 | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210383-003 | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210383-001 | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210383-002 | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210383-003 | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210383-001 | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210383-002 | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210383-003 | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210383-001 | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210383-002 | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210383-003 | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210383-001 | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210383-002 | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210383-003 | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210383-001 | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210383-002 | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210383-003 | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210383-001 | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE / INJECTION | AP | 2019-02-14 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210383-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210383-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210383-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210383-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210383-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210383-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210383-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210383-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210383-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210383-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210383-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210383-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210383-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210383-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210383-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210383-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210383-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210383-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210383-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210383-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210383-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210383-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210383-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210383-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210383-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210383-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210383-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210383-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210383-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210383-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210383-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210383-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210383-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210383-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210383-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210383-003 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210383-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210383-002 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210383-003 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210383-001 | AP | 1 | 8072bd15b7f6… |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50742-497-53 | 50742049753 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50742-497-53) > 52.6 mL in 1 VIAL, SINGLE-DOSE | 2019-02-26 | 0000-00-00 | No | No | Current |