Ciprofloxacin
- Product NDC
- 50090-4600
- 11-digit product format
- 500904600
- Labeler code
- 50090
- Product ID
- 50090-4600_23da7d25-ba5c-4dcb-9351-e3ddfebdf614
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ciprofloxacin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA076126
- Marketing category
- ANDA
- Marketing start
- 2009-10-10
- 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
- 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 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-4600-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-f666-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987 |
| 50090-4600-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-f666-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987 |
| 50090-4600-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-f666-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987 |
| 50090-4600-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-f666-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987 |
| 50090-4600-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-f666-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987 |
| 50090-4600-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-f666-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987 |
| 50090-4600-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-f666-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987 |
| 50090-4600-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-f666-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-4600-0 | Ciprofloxacin | 6 in 1 BOTTLE | TABLET, FILM COATED | 6 | | 3 |
| 50090-4600-1 | Ciprofloxacin | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 3 |
| 50090-4600-2 | Ciprofloxacin | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 3 |
| 50090-4600-3 | Ciprofloxacin | 3 in 1 BOTTLE | TABLET, FILM COATED | 3 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-4600 | CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, Legacy NDC, 4 package rows | 20191106_6e37322b-89d3-4b66-8e1b-c4ad79eed173.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 |
|---|
| 50090-4600-0 | 50090460000 | 6 TABLET, FILM COATED in 1 BOTTLE (50090-4600-0) | 2019-10-11 | 0000-00-00 | No | No | Current |
| 50090-4600-1 | 50090460001 | 14 TABLET, FILM COATED in 1 BOTTLE (50090-4600-1) | 2019-10-11 | 0000-00-00 | No | No | Current |
| 50090-4600-2 | 50090460002 | 10 TABLET, FILM COATED in 1 BOTTLE (50090-4600-2) | 2019-10-11 | 0000-00-00 | No | No | Current |
| 50090-4600-3 | 50090460003 | 3 TABLET, FILM COATED in 1 BOTTLE (50090-4600-3) | 2019-10-11 | 0000-00-00 | No | No | Current |