Loratadine 10 mg
- Product NDC
- 49483-732
- 11-digit product format
- 494830732
- Labeler code
- 49483
- Product ID
- 49483-732_2c80ea14-8491-4d26-e063-6294a90aecf0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine Tablets USP, 10 mg
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TIME CAP LABORATORIES, INC.
- Application
- ANDA219223
- Marketing category
- ANDA
- Marketing start
- 2025-01-25
- 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 10 mg
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49483-732-65 | Loratadine 10 mg | 365 in 1 BOTTLE | TABLET | 365 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49483-732 | LORATADINE 10 MG (LORATADINE TABLETS USP, 10 MG) TABLET [TIME CAP LABORATORIES, INC.] | 1 | Current NDC, 1 package rows | 20250126_2c80ea14-8490-4d26-e063-6294a90aecf0.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 |
|---|
| 49483-732-65 | 49483073265 | 365 TABLET in 1 BOTTLE (49483-732-65) | 365 tablet | 2025-01-25 | No | No | Historical |