Loratadine
- Product NDC
- 43598-756
- 11-digit product format
- 435980756
- Labeler code
- 43598
- Product ID
- 43598-756_33224371-b336-2c1e-63dd-7a8ce9d195ff
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA212795
- Marketing category
- ANDA
- Marketing start
- 2021-05-19
- 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-756 | LORATADINE TABLET [DR. REDDY'S LABORATORIES INC.] | 1 | Current NDC | 20230228_9357186a-9452-e139-01d8-6b8c6f6a2c6b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 43598-756-10 | 43598075610 | 1 BLISTER PACK in 1 CARTON (43598-756-10) / 10 TABLET in 1 BLISTER PACK | 1 blister pack | 2023-07-14 | No | No | Current |
| 43598-756-30 | 43598075630 | 3 BLISTER PACK in 1 CARTON (43598-756-30) / 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2023-07-14 | No | No | Current |