Epirubicin Hydrochloride
- Product NDC
- 0143-9203
- 11-digit product format
- 001439203
- Labeler code
- 0143
- Product ID
- 0143-9203_a854383a-1d91-456c-baae-2e4011faf1a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Epirubicin Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA065289
- Marketing category
- ANDA
- Marketing start
- 2007-08-07
- Marketing end
- 0000-00-00
- Substance
- EPIRUBICIN HYDROCHLORIDE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9203 | EPIRUBICIN HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 6 | Legacy NDC | 20240724_a24ff5f2-0a9a-4222-9135-1d4094ddd2e0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0143-9203-01 | 00143920301 | 1 VIAL in 1 BOX (0143-9203-01) > 50 mL in 1 VIAL | 1 vial | 2007-08-07 | 0000-00-00 | No | No | Current |