GEMCITABINE HYDROCHLORIDE
- Product NDC
- 69097-313
- 11-digit product format
- 690970313
- Labeler code
- 69097
- Product ID
- 69097-313_3a57a223-6d5c-4ca9-b504-01a25e7cee18
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GEMCITABINE HYDROCHLORIDE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Cipla USA Inc.
- Application
- ANDA078759
- Marketing category
- ANDA
- Marketing start
- 2011-07-25
- Marketing end
- 0000-00-00
- Substance
- GEMCITABINE HYDROCHLORIDE
- Active strength
- 200 mg/5mL
- 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
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-313 | GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CIPLA USA INC.] | 9 | Legacy NDC | 20200917_b4e58ed9-edb8-4337-ad0d-29e075e66f1d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69097-313-37 | 69097031337 | 1 VIAL, SINGLE-USE in 1 CARTON (69097-313-37) > 5 mL in 1 VIAL, SINGLE-USE | 2011-07-25 | 0000-00-00 | No | No | Current |