Loratadine
- Product NDC
- 68210-4110
- 11-digit product format
- 682104110
- Labeler code
- 68210
- Product ID
- 68210-4110_292df514-5dba-2a76-e063-6394a90acee6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Spirit Pharmaceuticals LLC
- Application
- ANDA210722
- Marketing category
- ANDA
- Marketing start
- 2020-09-11
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68210-4110-1 | Loratadine | 365 in 1 BOTTLE | TABLET | 365 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68210-4110 | LORATADINE TABLET [SPIRIT PHARMACEUTICALS LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241215_af0cdab2-27a4-5f30-e053-2a95a90a5e71.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 |
|---|
| 68210-4110-1 | 68210411001 | 365 TABLET in 1 BOTTLE (68210-4110-1) | 365 tablet | 2020-09-11 | 0000-00-00 | No | No | Current |