Gatifloxacin
- Product NDC
- 61314-672
- 11-digit product format
- 613140672
- Labeler code
- 61314
- Product ID
- 61314-672_20dfbbfa-5c67-4ac4-a90a-a7dd29395e71
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gatifloxacin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Sandoz Inc
- Application
- ANDA204227
- Marketing category
- ANDA
- Marketing start
- 2016-10-03
- Substance
- GATIFLOXACIN
- Active strength
- 5 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
- Gatifloxacin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GATIFLOXACIN | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L4618BD7KJ |
| Rxcui | 992395 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61314-672-25 | Gatifloxacin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 14 |
| 61314-672-25 | Gatifloxacin | 2.5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 2.5 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61314-672 | GATIFLOXACIN SOLUTION/ DROPS [SANDOZ INC] | 14 | Current NDC, Legacy NDC, 2 package rows | 20220218_9e6fcd14-1fee-493f-811c-e18cbfbee65b.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 |
|---|
| 61314-672-25 | 61314067225 | 1 BOTTLE, DROPPER in 1 CARTON (61314-672-25) / 2.5 mL in 1 BOTTLE, DROPPER | 2016-10-03 | 0000-00-00 | No | No | Current |