Loratadine
- Product NDC
- 62207-787
- 11-digit product format
- 622070787
- Labeler code
- 62207
- Product ID
- 62207-787_3b4cd1e9-fe92-7333-e063-6294a90af3f5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Granules India Limited
- Application
- ANDA210722
- Marketing category
- ANDA
- Marketing start
- 2020-01-08
- 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 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62207-787 | LORATADINE TABLET [GRANULES INDIA LIMITED] | 4 | Current NDC, Legacy NDC, 3 package rows | 20230215_9bae1ba3-c0da-23a2-e053-2a95a90a58ed.zip |
| 62207-787 | LORATADINE TABLET [GRANULES INDIA LTD] | 4 | Current NDC, Legacy NDC, 3 package rows | 20200101_0dee9036-d51f-4d7f-b5e2-4f6940249eef.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 |
|---|
| 62207-787-49 | 62207078749 | 1000 TABLET in 1 BOTTLE (62207-787-49) | 1000 tablet | 2020-01-08 | 0000-00-00 | No | No | Current |
| 62207-787-51 | 62207078751 | 10 TABLET in 1 BOTTLE (62207-787-51) | 10 tablet | 2020-01-01 | 0000-00-00 | No | No | Current |
| 62207-787-59 | 62207078759 | 12 BLISTER PACK in 1 CARTON (62207-787-59) > 10 TABLET in 1 BLISTER PACK | 12 blister pack | 2020-01-01 | 0000-00-00 | No | No | Current |
| 62207-787-88 | 62207078788 | 5 POUCH in 1 BOX (62207-787-88) / 20000 TABLET in 1 POUCH | 5 pouch | 2020-03-16 | 0000-00-00 | No | No | Current |