Ciprofloxacin
- Product NDC
- 62135-309
- 11-digit product format
- 621350309
- Labeler code
- 62135
- Product ID
- 62135-309_410cec1e-83d0-dbed-e063-6394a90a6513
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ciprofloxacin hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Chartwell RX, LLC.
- Application
- ANDA076896
- Marketing category
- ANDA
- Marketing start
- 2021-04-13
- Substance
- CIPROFLOXACIN HYDROCHLORIDE
- Active strength
- 500 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 | 500 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 |
|---|
| 62135-309-01 | Ciprofloxacin | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 4 |
| 62135-309-05 | Ciprofloxacin | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 4 |
| 62135-309-10 | Ciprofloxacin | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 4 |
| 62135-309-20 | Ciprofloxacin | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 4 |
| 62135-309-28 | Ciprofloxacin | 28 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 28 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-309 | CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [CHARTWELL RX, LLC.] | 3 | Current NDC, Legacy NDC, 5 package rows | 20230120_6c64aa79-d087-4568-904c-3a0638b91e69.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 |
|---|
| 62135-309-01 | 62135030901 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-01) | 2021-04-13 | 0000-00-00 | No | No | Current |
| 62135-309-05 | 62135030905 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-05) | 2021-04-13 | 0000-00-00 | No | No | Current |
| 62135-309-10 | 62135030910 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-10) | 2021-04-13 | 0000-00-00 | No | No | Current |
| 62135-309-20 | 62135030920 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-20) | 2021-04-13 | 0000-00-00 | No | No | Current |
| 62135-309-28 | 62135030928 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-28) | 2021-04-13 | 0000-00-00 | No | No | Current |