Loratadine 10mg
- Product NDC
- 25000-092
- 11-digit product format
- 250000092
- Labeler code
- 25000
- Product ID
- 25000-092_aa667b5f-a4ac-4129-bae9-f9c1de776629
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine 10mg
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- MARKSANS PHARMA LIMITED
- Application
- ANDA219223
- Marketing category
- ANDA
- Marketing start
- 2024-11-21
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Loratadine 10mg
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LORATADINE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 311372 |
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25000-092 | LORATADINE 10MG TABLET [MARKSANS PHARMA LIMITED] | 4 | Current NDC, 7 package rows | 20241127_3360d02d-612d-4cc5-acc9-2cc93713c387.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 |
|---|
| 25000-092-03 | 25000009203 | 1 BOTTLE in 1 CARTON (25000-092-03) / 30 TABLET in 1 BOTTLE | 1 bottle | 2024-11-21 | No | No | Current |
| 25000-092-79 | 25000009279 | 1 BOTTLE in 1 CARTON (25000-092-79) / 150 TABLET in 1 BOTTLE | 1 bottle | 2024-11-21 | No | No | Current |
| 25000-092-80 | 25000009280 | 365 TABLET in 1 BOTTLE (25000-092-80) | 365 tablet | 2024-11-21 | No | No | Current |
| 25000-092-81 | 25000009281 | 2 BLISTER PACK in 1 CARTON (25000-092-81) / 7 TABLET in 1 BLISTER PACK | 2 blister pack | 2024-11-21 | No | No | Current |