Loratadine
- Product NDC
- 63868-151
- 11-digit product format
- 638680151
- Labeler code
- 63868
- Product ID
- 63868-151_08f2bf78-eba5-41ce-bcb0-733e2760d44b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chain Drug Marketing Association Inc.
- Application
- ANDA076134
- Marketing category
- ANDA
- Marketing start
- 2003-08-19
- 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
- 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 |
|---|
| 63868-151-01 | Loratadine | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 63868-151-10 | Loratadine | 10 in 1 BLISTER PACK | TABLET | 10 | | 2 |
| 63868-151-30 | Loratadine | 30 in 1 BLISTER PACK | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63868-151 | LORATADINE TABLET [CHAIN DRUG MARKETING ASSOCIATION INC.] | 2 | Current NDC, Legacy NDC, 3 package rows | 20180829_b4edf5b1-398d-405a-8a42-76044b31ebb7.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 |
|---|
| 63868-151-01 | 63868015101 | 100 TABLET in 1 BOTTLE (63868-151-01) | 100 tablet | 2003-08-19 | 0000-00-00 | No | No | Current |
| 63868-151-10 | 63868015110 | 10 TABLET in 1 BLISTER PACK (63868-151-10) | 10 tablet | 2003-08-19 | 0000-00-00 | No | No | Current |
| 63868-151-30 | 63868015130 | 30 TABLET in 1 BLISTER PACK (63868-151-30) | 30 tablet | 2003-08-19 | 0000-00-00 | No | No | Current |