Ciprofloxacin Hydrochloride
- Product NDC
- 69367-385
- 11-digit product format
- 693670385
- Labeler code
- 69367
- Product ID
- 69367-385_e679760f-b4d3-4a21-9d47-40c2355bc2c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ciprofloxacin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA076593
- Marketing category
- ANDA
- Marketing start
- 2024-05-23
- Substance
- CIPROFLOXACIN HYDROCHLORIDE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ciprofloxacin Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CIPROFLOXACIN HYDROCHLORIDE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4BA73M5E37 |
| Rxcui | 197511, 197512, 309309 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69367-385-01 | Ciprofloxacin Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69367-385 | CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC] | 1 | Current NDC, 1 package rows | 20240605_c47250c2-bece-46b5-8b3b-b7c97d9005d8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69367-385-01 | 69367038501 | 100 TABLET, FILM COATED in 1 BOTTLE (69367-385-01) | 2024-05-23 | No | No | Current |