Loratadine
- Product NDC
- 68071-2392
- 11-digit product format
- 680712392
- Labeler code
- 68071
- Product ID
- 68071-2392_4c5020ce-2905-00f7-e063-6394a90a61b2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA075209
- Marketing category
- ANDA
- Marketing start
- 2020-02-01
- 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 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-2392-3 | Loratadine | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2392 | LORATADINE TABLET [NUCARE PHARMACEUTICALS,INC.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20210427_c0e3057d-2dd2-de2b-e053-2995a90a1a1d.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 |
|---|
| 68071-2392-3 | 68071239203 | 30 TABLET in 1 BOTTLE (68071-2392-3) | 30 tablet | 2021-04-26 | 0000-00-00 | No | No | Current |