Ciprofloxacin
- Product NDC
- 65862-078
- 11-digit product format
- 658620078
- Labeler code
- 65862
- Product ID
- 65862-078_9e7eb1ac-3e09-4b4c-8ce1-ab16c3102a10
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ciprofloxacin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA077859
- Marketing category
- ANDA
- Marketing start
- 2007-04-26
- Marketing end
- 2027-01-31
- Substance
- CIPROFLOXACIN HYDROCHLORIDE
- Active strength
- 750 mg/1
- Pharmacologic classes
- Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ciprofloxacin
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CIPROFLOXACIN HYDROCHLORIDE | 750 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 |
|---|
| 65862-078-01 | Ciprofloxacin | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 33 |
| 65862-078-05 | Ciprofloxacin | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 33 |
| 65862-078-20 | Ciprofloxacin | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 33 |
| 65862-078-50 | Ciprofloxacin | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 33 |
| 65862-078-98 | Ciprofloxacin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 33 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CIPROFLOXACIN HYDROCHLORIDE | ACTIVE INGREDIENT | 4BA73M5E37 | CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 14 | |
| CIPROFLOXACIN | ACTIVE MOIETY | 5E8K9I0O4U | CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 14 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 14 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 14 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 14 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 14 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 14 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 14 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 14 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 14 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-078 | CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 32 | Current NDC, Legacy NDC, 5 package rows | 20250501_2b3b6a9f-259c-4736-b88f-f49d1eb64286.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 |
|---|
| 65862-078-01 | 65862007801 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-078-01) | 2007-04-26 | 0000-00-00 | No | No | Current |
| 65862-078-05 | 65862007805 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-078-05) | 2007-04-26 | 0000-00-00 | No | No | Current |
| 65862-078-20 | 65862007820 | 20 TABLET, FILM COATED in 1 BOTTLE (65862-078-20) | 2007-04-26 | 0000-00-00 | No | No | Current |
| 65862-078-50 | 65862007850 | 50 TABLET, FILM COATED in 1 BOTTLE (65862-078-50) | 2007-04-26 | 2027-01-31 | No | No | Current |
| 65862-078-98 | 65862007898 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-078-98) | 2007-04-26 | 0000-00-00 | No | No | Current |