Loratadine
- Product NDC
- 0904-6852
- 11-digit product format
- 009046852
- Labeler code
- 0904
- Product ID
- 0904-6852_7c3836c3-7476-49b8-ac03-11718d17c813
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA076301
- Marketing category
- ANDA
- Marketing start
- 2005-02-21
- 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 |
|---|
| 0904-6852 | LORATADINE TABLET [MAJOR PHARMACEUTICALS] | 8 | Current NDC, Legacy NDC, 10 package rows | 20250426_dee25423-377b-4b94-a4a8-0dfb8f51aaab.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 |
|---|
| 0904-6852-07 | 00904685207 | 30 BLISTER PACK in 1 CARTON (0904-6852-07) > 1 TABLET in 1 BLISTER PACK | 30 blister pack | 2019-08-01 | 0000-00-00 | No | No | Current |
| 0904-6852-60 | 00904685260 | 1 BOTTLE in 1 CARTON (0904-6852-60) > 100 TABLET in 1 BOTTLE | 1 bottle | 2018-12-06 | 0000-00-00 | No | No | Current |
| 0904-6852-61 | 00904685261 | 100 BLISTER PACK in 1 CARTON (0904-6852-61) > 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2005-02-21 | 0000-00-00 | No | No | Current |
| 0904-6852-72 | 00904685272 | 1 BOTTLE in 1 CARTON (0904-6852-72) / 300 TABLET in 1 BOTTLE | 1 bottle | 2019-06-04 | 0000-00-00 | No | No | Current |
| 0904-6852-89 | 00904685289 | 1 BOTTLE in 1 CARTON (0904-6852-89) / 90 TABLET in 1 BOTTLE | 1 bottle | 2019-04-08 | 0000-00-00 | No | No | Current |