OFLOXACIN
- Product NDC
- 71209-097
- 11-digit product format
- 712090097
- Labeler code
- 71209
- Product ID
- 71209-097_85ff09b7-6b73-44bd-a654-11fbab9efdbe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OFLOXACIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cadila Pharmaceuticals Limited
- Application
- ANDA091656
- Marketing category
- ANDA
- Marketing start
- 2015-12-29
- Substance
- OFLOXACIN
- Active strength
- 200 mg/1
- Pharmacologic classes
- Quinolone Antimicrobial [EPC], Quinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OFLOXACIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OFLOXACIN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A4P49JAZ9H |
| Rxcui | 198048, 198049, 198050 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71209-097-02 | OFLOXACIN | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 15 |
| 71209-097-05 | OFLOXACIN | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 15 |
| 71209-097-10 | OFLOXACIN | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71209-097 | OFLOXACIN TABLET, FILM COATED [CADILA PHARMACEUTICALS LIMITED] | 15 | Current NDC, Legacy NDC, 3 package rows | 20240920_c677b35c-0432-4ee5-af57-1f95449c48b6.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 |
|---|
| 71209-097-02 | 71209009702 | 50 TABLET, FILM COATED in 1 BOTTLE (71209-097-02) | 2015-12-29 | 0000-00-00 | No | No | Current |
| 71209-097-05 | 71209009705 | 100 TABLET, FILM COATED in 1 BOTTLE (71209-097-05) | 2015-12-29 | 0000-00-00 | No | No | Current |
| 71209-097-10 | 71209009710 | 500 TABLET, FILM COATED in 1 BOTTLE (71209-097-10) | 2015-12-29 | 0000-00-00 | No | No | Current |