OFLOXACIN
- Product NDC
- 75834-112
- 11-digit product format
- 758340112
- Labeler code
- 75834
- Product ID
- 75834-112_67a823b3-3e2d-4483-98e5-99fbddc0c8f5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OFLOXACIN
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Nivagen Pharmaceuticals, Inc.
- Application
- ANDA091656
- Marketing category
- ANDA
- Marketing start
- 2016-07-15
- Substance
- OFLOXACIN
- Active strength
- 400 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 | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A4P49JAZ9H |
| Rxcui | 198048, 198049, 198050 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 75834-112-01 | 2022-02-15 | C162847 | 48780-1 | 9d75b9d1-1914-f424-e053-dadaa90a57ce | OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. |
| 75834-112-05 | 2022-02-15 | C162847 | 48780-1 | 9d75b9d1-1914-f424-e053-dadaa90a57ce | OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. |
| 75834-112-50 | 2022-02-15 | C162847 | 48780-1 | 9d75b9d1-1914-f424-e053-dadaa90a57ce | OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. |
| 75834-112-01 | 2022-01-28 | C162847 | 48780-1 | 9d75b9d1-1914-f424-e053-dadaa90a57ce | OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. |
| 75834-112-05 | 2022-01-28 | C162847 | 48780-1 | 9d75b9d1-1914-f424-e053-dadaa90a57ce | OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. |
| 75834-112-50 | 2022-01-28 | C162847 | 48780-1 | 9d75b9d1-1914-f424-e053-dadaa90a57ce | OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. |
| 75834-112-01 | 2020-05-06 | C162847 | 48780-1 | 9d75b9d1-1914-f424-e053-dadaa90a57ce | OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. |
| 75834-112-05 | 2020-05-06 | C162847 | 48780-1 | 9d75b9d1-1914-f424-e053-dadaa90a57ce | OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. |
| 75834-112-50 | 2020-05-06 | C162847 | 48780-1 | 9d75b9d1-1914-f424-e053-dadaa90a57ce | OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. |
| 75834-112-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1914-f424-e053-dadaa90a57ce | OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. |
| 75834-112-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1914-f424-e053-dadaa90a57ce | OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. |
| 75834-112-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1914-f424-e053-dadaa90a57ce | OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75834-112-01 | OFLOXACIN | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 4 |
| 75834-112-05 | OFLOXACIN | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 4 |
| 75834-112-50 | OFLOXACIN | 50 in 1 BOTTLE | TABLET, COATED | 50 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75834-112 | OFLOXACIN TABLET, COATED [NIVAGEN PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20220216_ee1bf431-97fa-4aba-9cc3-0cfcea779ca2.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 |
|---|
| 75834-112-01 | 75834011201 | 100 TABLET, COATED in 1 BOTTLE (75834-112-01) | 2016-07-15 | 0000-00-00 | No | No | Current |
| 75834-112-05 | 75834011205 | 500 TABLET, COATED in 1 BOTTLE (75834-112-05) | 2016-07-15 | 0000-00-00 | No | No | Current |
| 75834-112-50 | 75834011250 | 50 TABLET, COATED in 1 BOTTLE (75834-112-50) | 2016-07-15 | 0000-00-00 | No | No | Current |