Cefepime Hydrochloride
- Product NDC
- 0143-9383
- 11-digit product format
- 001439383
- Labeler code
- 0143
- Product ID
- 0143-9383_c31d1803-2676-4944-92ef-0f6f5e3fee16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefepime Hydrochloride
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA214402
- Marketing category
- ANDA
- Marketing start
- 2025-09-22
- Substance
- CEFEPIME HYDROCHLORIDE
- Active strength
- 2 g/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cefepime Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CEFEPIME HYDROCHLORIDE | 2 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I8X1O0607P |
| Rxcui | 1665088, 1665093 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9383-10 | Cefepime Hydrochloride | 10 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 10 | | 3 |
| 0143-9383-10 | Cefepime Hydrochloride | 1 in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 1 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0143-9383-10 | 00143938310 | 10 VIAL in 1 CARTON (0143-9383-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | 10 vial | 2025-09-22 | No | No | Historical |