Ofloxacin
- Product NDC
- 63187-268
- 11-digit product format
- 631870268
- Labeler code
- 63187
- Product ID
- 63187-268_331a9c17-9946-48a6-bc37-af84ecdea26a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ofloxacin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Proficient Rx LP
- Application
- ANDA076622
- Marketing category
- ANDA
- Marketing start
- 2004-05-14
- Substance
- OFLOXACIN
- Active strength
- 3 mg/mL
- 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 | 3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A4P49JAZ9H |
| Rxcui | 312075 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-268-05 | Ofloxacin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 5 |
| 63187-268-05 | Ofloxacin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-268 | OFLOXACIN SOLUTION/ DROPS [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 2 package rows | 20220409_c8020ad4-ac74-4ceb-863e-94da605cf23f.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 |
|---|
| 63187-268-05 | 63187026805 | 1 BOTTLE, DROPPER in 1 CARTON (63187-268-05) / 5 mL in 1 BOTTLE, DROPPER | 2019-01-01 | 0000-00-00 | No | No | Current |