GEMCITABINE
- Product NDC
- 68001-350
- Requested package NDC
- 68001-350-68
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 68001-350 | 68001-350-68 | D | Discontinued by firm | 2026-08-17 |
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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 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… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209604-001 | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209604-002 | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209604-003 | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209604-004 | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2017-08-03 | d8e5a09893c0… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a2b7d477-0e35-4772-8a9d-99c71e3e210b | Product name | 2 | 20190614 |
| 4c31c9b8-06d5-4f83-9eb7-cd946af7067a | Product name | 5 | 20190612 |
| a12a1c0c-65f2-45a0-8bf0-7dfc55c750b6 | Product name | 1 | 20180829 |
| d2980057-8cff-4896-979e-b4c394974cfd | Product name | 1 | 20170829 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68001-350-68 | GEMCITABINE | 15 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 15 | 5 | |
| 68001-350-68 | GEMCITABINE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 5 |
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 68001-350-68 68001-350 68001035068 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1998783 | gemcitabine 100 MG/mL Injectable Solution | PSN | 4031017d-d768-46de-8081-476bcb883f5e | 5 |
| 1998783 | gemcitabine 100 MG/ML Injectable Solution | SCD | 4031017d-d768-46de-8081-476bcb883f5e | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68001-350-68 | 68001035068 | 1 VIAL, MULTI-DOSE in 1 CARTON (68001-350-68) > 15 mL in 1 VIAL, MULTI-DOSE | 2018-05-25 | 0000-00-00 | No | No | Current |