Latanoprostene Bunod Ophthalmic Solution, 0.024%
- Product NDC
- 68083-563
- 11-digit product format
- 680830563
- Labeler code
- 68083
- Product ID
- 68083-563_fac898b8-b3e7-4db5-a3ff-a3ebcdca84cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Latanoprostene Bunod Ophthalmic Solution, 0.024%
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Gland Pharma Limited
- Application
- ANDA217387
- Marketing category
- ANDA
- Marketing start
- 2025-04-29
- Substance
- LATANOPROSTENE BUNOD
- Active strength
- .24 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Latanoprostene Bunod Ophthalmic Solution, 0.024%
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LATANOPROSTENE BUNOD | .24 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I6393O0922 |
| Rxcui | 1988394 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-563-01 | Latanoprostene Bunod Ophthalmic Solution, 0.024% | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 6 |
| 68083-563-01 | Latanoprostene Bunod Ophthalmic Solution, 0.024% | 2.5 mL in 1 BOTTLE | SOLUTION/ DROPS | 2.5 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-563 | LATANOPROSTENE BUNOD OPHTHALMIC SOLUTION, 0.024% SOLUTION/ DROPS [GLAND PHARMA LIMITED] | 6 | Current NDC, 2 package rows | 20250503_1beedfbd-5e2b-4ab1-ab8e-8320e69af1ea.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-563-01 | 68083056301 | 1 BOTTLE in 1 CARTON (68083-563-01) / 2.5 mL in 1 BOTTLE | 1 bottle | 2025-04-29 | No | No | Current |