Gemcitabine
- Product NDC
- 60505-6114
- 11-digit product format
- 605056114
- Labeler code
- 60505
- Product ID
- 60505-6114_22629a2c-90ab-6746-fe2a-5909ceb6f946
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GEMCITABINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Apotex Corp.
- Application
- ANDA206776
- Marketing category
- ANDA
- Marketing start
- 2018-03-20
- Marketing end
- 2021-01-31
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 60505-6114 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 60505-6114 | 60505-6114-0 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A206776-001 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 200MG/5.26ML (38MG/ML) | INJECTABLE / INJECTION | | | 2017-05-23 |
| A206776-002 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 1GM/26.3ML (38MG/ML) | INJECTABLE / INJECTION | | | 2017-05-23 |
| A206776-003 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 2GM/52.6ML (38MG/ML) | INJECTABLE / INJECTION | | | 2017-05-23 |