Ciprofloxacin
- Product NDC
- 53401-301
- 11-digit product format
- 534010301
- Labeler code
- 53401
- Product ID
- 53401-301_9a9adf9b-389b-40f2-980e-38d7c5b15033
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ciprofloxacin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - New Jersey, LLC
- Application
- ANDA077859
- Marketing category
- ANDA
- Marketing start
- 2009-08-01
- Marketing end
- 0000-00-00
- Substance
- CIPROFLOXACIN HYDROCHLORIDE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Quinolone Antimicrobial [EPC],Quinolones [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53401-301-20 | Ciprofloxacin | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 2 |
| 53401-301-99 | Ciprofloxacin | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CIPROFLOXACIN HYDROCHLORIDE | ACTIVE INGREDIENT | 4BA73M5E37 | CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 2 | |
| CIPROFLOXACIN | ACTIVE MOIETY | 5E8K9I0O4U | CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 2 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 2 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 2 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53401-301 | CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] | 2 | Legacy NDC, 2 package rows | 20140410_489c5c7d-75e3-4b98-b7d5-3c61e2f98adf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53401-301-20 | 53401030120 | 20 in 1 BOTTLE, PLASTIC | Historical |
| 53401-301-99 | 53401030199 | 100 in 1 BOTTLE, PLASTIC | Historical |