Ciprofloxacin Hydrochloride
- Product NDC
- 68788-8198
- 11-digit product format
- 687888198
- Labeler code
- 68788
- Product ID
- 68788-8198_6382ad56-0b87-4376-896e-97ce0f08028f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ciprofloxacin Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- NDA019992
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2022-05-23
- Substance
- CIPROFLOXACIN HYDROCHLORIDE
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ciprofloxacin Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CIPROFLOXACIN HYDROCHLORIDE | 3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4BA73M5E37 |
| Rxcui | 309307 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8198-5 | Ciprofloxacin Hydrochloride | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
| 68788-8198-5 | Ciprofloxacin Hydrochloride | 5 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8198 | CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250112_78641acd-eedf-4b68-bb18-da0874415f59.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 |
|---|
| 68788-8198-5 | 68788819805 | 1 BOTTLE, PLASTIC in 1 CARTON (68788-8198-5) / 5 mL in 1 BOTTLE, PLASTIC | 2022-05-23 | 0000-00-00 | No | No | Current |