Loratadine
- Product NDC
- 68001-438
- 11-digit product format
- 680010438
- Labeler code
- 68001
- Product ID
- 68001-438_e1e021de-1501-2fe3-e053-2a95a90a7be9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA208314
- Marketing category
- ANDA
- Marketing start
- 2020-08-26
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-438 | LORATADINE TABLET [BLUEPOINT LABORATORIES] | 4 | Current NDC, Legacy NDC, 8 package rows | 20220624_adc506ed-7a7a-facc-e053-2a95a90ae147.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 |
|---|
| 68001-438-00 | 68001043800 | 1 BOTTLE in 1 CARTON (68001-438-00) / 100 TABLET in 1 BOTTLE | 1 bottle | 2020-08-26 | 0000-00-00 | No | No | Current |
| 68001-438-04 | 68001043804 | 1 BOTTLE in 1 CARTON (68001-438-04) / 30 TABLET in 1 BOTTLE | 1 bottle | 2020-08-26 | 0000-00-00 | No | No | Current |
| 68001-438-16 | 68001043816 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68001-438-96 | 68001043896 | 10 BLISTER PACK in 1 CARTON (68001-438-96) / 10 TABLET in 1 BLISTER PACK (68001-438-16) | 10 blister pack | 2020-08-26 | 0000-00-00 | No | No | Current |
| 68001-438-97 | 68001043897 | 1 BOTTLE in 1 CARTON (68001-438-97) / 300 TABLET in 1 BOTTLE | 1 bottle | 2020-08-26 | 0000-00-00 | No | No | Current |