Gemcitabine
- Product NDC
- 72485-221
- 11-digit product format
- 724850221
- Labeler code
- 72485
- Product ID
- 72485-221_52a15e83-e33d-42e7-9270-636b5b59d63b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GEMCITABINE HYDROCHLORIDE
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Armas Pharmaceuticals Inc.
- Application
- ANDA210991
- Marketing category
- ANDA
- Marketing start
- 2020-01-15
- Substance
- GEMCITABINE HYDROCHLORIDE
- Active strength
- 200 mg/5.26mL
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72485-221-02 | Gemcitabine | 1 in 1 CARTON | INJECTION | 1 | | 1 |
| 72485-221-02 | Gemcitabine | 5.26 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 5.26 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72485-221 | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION [ARMAS PHARMACEUTICALS INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20200117_57b80f66-208d-4903-9443-e4c9239e3207.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72485-221-02 | 72485022102 | 1 VIAL, SINGLE-DOSE in 1 CARTON (72485-221-02) / 5.26 mL in 1 VIAL, SINGLE-DOSE | 2020-01-15 | 0000-00-00 | No | No | Current |