Loratadine Allergy Relief
- Product NDC
- 10135-763
- 11-digit product format
- 101350763
- Labeler code
- 10135
- Product ID
- 10135-763_43e1e645-7da5-86de-e063-6394a90a7f3a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc.
- Application
- ANDA076134
- Marketing category
- ANDA
- Marketing start
- 2022-10-01
- 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 Allergy Relief
- 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 |
|---|
| 10135-763-03 | Loratadine Allergy Relief | 300 in 1 BOTTLE | TABLET | 300 | | 4 |
| 10135-763-30 | Loratadine Allergy Relief | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 10135-763-90 | Loratadine Allergy Relief | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-763 | LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [MARLEX PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 3 package rows | 20241010_ec08a6ee-3d71-0fa9-e053-2995a90a9cb1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 10135-763-03 | 10135076303 | 300 TABLET in 1 BOTTLE (10135-763-03) | 300 tablet | 2022-10-01 | 0000-00-00 | No | No | Current |
| 10135-763-30 | 10135076330 | 30 TABLET in 1 BOTTLE (10135-763-30) | 30 tablet | 2022-10-01 | 0000-00-00 | No | No | Current |
| 10135-763-90 | 10135076390 | 90 TABLET in 1 BOTTLE (10135-763-90) | 90 tablet | 2022-10-01 | 0000-00-00 | No | No | Current |