Loratadine
- Product NDC
- 0904-7511
- 11-digit product format
- 009047511
- Labeler code
- 0904
- Product ID
- 0904-7511_9f222415-3471-459d-9401-6c73d09b0f4d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA076301
- Marketing category
- ANDA
- Marketing start
- 2025-03-18
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Loratadine
- Listing expiration
- 2027-12-31
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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7511-61 | Loratadine | 1 in 1 BLISTER PACK | TABLET | 1 | | 2 |
| 0904-7511-61 | Loratadine | 100 in 1 CARTON | TABLET | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7511 | LORATADINE TABLET [MAJOR PHARMACEUTICALS] | 1 | Current NDC, 2 package rows | 20250321_60162446-4fa1-4ee3-ae20-19fadc2491ab.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 |
|---|
| 0904-7511-61 | 00904751161 | 100 BLISTER PACK in 1 CARTON (0904-7511-61) / 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2025-03-18 | No | No | Historical |