Cipro
- Product NDC
- 50419-754
- 11-digit product format
- 504190754
- Labeler code
- 50419
- Product ID
- 50419-754_1b112839-6cf0-466a-9188-86fc5b1549f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ciprofloxacin hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.
- Application
- NDA019537
- Marketing category
- NDA
- Marketing start
- 1987-10-22
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cipro
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CIPROFLOXACIN HYDROCHLORIDE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4BA73M5E37 |
| Rxcui | 197511, 205769, 205770, 213224, 213226, 309308, 309309, 309310 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50419-754-01 | Cipro | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 32 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CIPROFLOXACIN HYDROCHLORIDE | ACTIVE INGREDIENT | 4BA73M5E37 | CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 15 | |
| CIPROFLOXACIN | ACTIVE MOIETY | 5E8K9I0O4U | CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 15 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 15 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 15 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 15 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 15 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | INACTIVE INGREDIENT | 74G4R6TH13 | CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 15 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 15 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 15 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 15 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 15 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 15 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 15 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 15 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 15 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50419-754 | CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 30 | Current NDC, Legacy NDC, 1 package rows | 20241218_888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0.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 |
|---|
| 50419-754-01 | 50419075401 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-754-01) | 1987-10-22 | 0000-00-00 | No | No | Current |