Loratadine
- Product NDC
- 68071-3414
- 11-digit product format
- 680713414
- Labeler code
- 68071
- Product ID
- 68071-3414_2d6c6076-d7cb-e793-e063-6294a90ac3b0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA076301
- Marketing category
- ANDA
- Marketing start
- 2008-10-15
- 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
- Brand name suffix
- antihistamine
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3414-3 | Loratadineantihistamine | 1 in 1 CARTON | TABLET | 1 | | 3 |
| 68071-3414-3 | Loratadineantihistamine | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3414 | LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, 2 package rows | 20250207_fc63689e-e449-ca8f-e053-6394a90a54a2.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 |
|---|
| 68071-3414-3 | 68071341403 | 1 BOTTLE in 1 CARTON (68071-3414-3) / 30 TABLET in 1 BOTTLE | 1 bottle | 2023-05-23 | No | No | Current |