LORATADINE
- Product NDC
- 51316-502
- 11-digit product format
- 513160502
- Labeler code
- 51316
- Product ID
- 51316-502_28e49606-cbf6-7029-e063-6394a90ae3b7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- LORATADINE
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- CVS PHARMACY, INC
- Application
- ANDA212795
- Marketing category
- ANDA
- Marketing start
- 2021-12-31
- Substance
- LORATADINE
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 672558 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51316-502-01 | LORATADINE | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 6 |
| 51316-502-01 | LORATADINE | 1 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 1 | | 6 |
| 51316-502-02 | LORATADINE | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 6 |
| 51316-502-02 | LORATADINE | 2 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 2 | | 6 |
| 51316-502-03 | LORATADINE | 3 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 3 | | 6 |
| 51316-502-03 | LORATADINE | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 6 |
| 51316-502-04 | LORATADINE | 4 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 4 | | 6 |
| 51316-502-04 | LORATADINE | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 6 |
| 51316-502-05 | LORATADINE | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 6 |
| 51316-502-05 | LORATADINE | 5 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 5 | | 6 |
| 51316-502-06 | LORATADINE | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 6 |
| 51316-502-06 | LORATADINE | 6 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 6 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51316-502 | LORATADINE TABLET, ORALLY DISINTEGRATING [CVS PHARMACY, INC] | 6 | Current NDC, Legacy NDC, 12 package rows | 20250101_4e74e322-7f6e-467c-96c0-9b531ddb429b.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 |
|---|
| 51316-502-01 | 51316050201 | 1 BLISTER PACK in 1 CARTON (51316-502-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 1 blister pack | 2021-12-31 | 0000-00-00 | No | No | Current |
| 51316-502-02 | 51316050202 | 2 BLISTER PACK in 1 CARTON (51316-502-02) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2 blister pack | 2021-12-31 | 0000-00-00 | No | No | Current |
| 51316-502-03 | 51316050203 | 3 BLISTER PACK in 1 CARTON (51316-502-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 3 blister pack | 2021-12-31 | 0000-00-00 | No | No | Current |
| 51316-502-04 | 51316050204 | 4 BLISTER PACK in 1 CARTON (51316-502-04) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 4 blister pack | 2021-12-31 | 0000-00-00 | No | No | Current |
| 51316-502-05 | 51316050205 | 5 BLISTER PACK in 1 CARTON (51316-502-05) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 5 blister pack | 2021-12-31 | 0000-00-00 | No | No | Current |
| 51316-502-06 | 51316050206 | 6 BLISTER PACK in 1 CARTON (51316-502-06) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 6 blister pack | 2021-12-31 | 0000-00-00 | No | No | Current |