Loratadine
- Product NDC
- 68016-094
- 11-digit product format
- 680160094
- Labeler code
- 68016
- Product ID
- 68016-094_29355692-7b20-4b38-8611-8a8f86e636a7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chain Drug Consortium, LLC
- Application
- ANDA208314
- Marketing category
- ANDA
- Marketing start
- 2018-04-16
- 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 |
|---|
| 68016-094 | LORATADINE TABLET [CHAIN DRUG CONSORTIUM, LLC] | 5 | Current NDC, Legacy NDC, 8 package rows | 20221105_21199958-ac67-4f72-8a8c-4d7d31fa9da4.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 |
|---|
| 68016-094-10 | 68016009410 | 1 BLISTER PACK in 1 CARTON (68016-094-10) / 10 TABLET in 1 BLISTER PACK | 1 blister pack | 2018-04-16 | 0000-00-00 | No | No | Current |
| 68016-094-30 | 68016009430 | 3 BLISTER PACK in 1 CARTON (68016-094-30) / 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2018-04-16 | 0000-00-00 | No | No | Current |
| 68016-094-60 | 68016009460 | 1 BOTTLE in 1 CARTON (68016-094-60) / 60 TABLET in 1 BOTTLE | 1 bottle | 2018-04-16 | 0000-00-00 | No | No | Current |
| 68016-094-90 | 68016009490 | 1 BOTTLE in 1 CARTON (68016-094-90) / 90 TABLET in 1 BOTTLE | 1 bottle | 2018-04-16 | 0000-00-00 | No | No | Current |