Loratadine
- Product NDC
- 66267-653
- 11-digit product format
- 662670653
- Labeler code
- 66267
- Product ID
- 66267-653_2b4e1a74-38aa-956a-e063-6294a90ae2f1
- 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#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 66267-653-07 | 2025-01-09 | C162847 | 48780-1 | f386c649-ce89-0266-e053-dadaa90a7c1a | Perrigo Loratadine Tablets, 10 mg Drug Facts |
| 66267-653-10 | 2025-01-09 | C162847 | 48780-1 | f386c649-ce89-0266-e053-dadaa90a7c1a | Perrigo Loratadine Tablets, 10 mg Drug Facts |
| 66267-653-14 | 2025-01-09 | C162847 | 48780-1 | f386c649-ce89-0266-e053-dadaa90a7c1a | Perrigo Loratadine Tablets, 10 mg Drug Facts |
| 66267-653-20 | 2025-01-09 | C162847 | 48780-1 | f386c649-ce89-0266-e053-dadaa90a7c1a | Perrigo Loratadine Tablets, 10 mg Drug Facts |
| 66267-653-30 | 2025-01-09 | C162847 | 48780-1 | f386c649-ce89-0266-e053-dadaa90a7c1a | Perrigo Loratadine Tablets, 10 mg Drug Facts |
| 66267-653-60 | 2025-01-09 | C162847 | 48780-1 | f386c649-ce89-0266-e053-dadaa90a7c1a | Perrigo Loratadine Tablets, 10 mg Drug Facts |
| 66267-653-90 | 2025-01-09 | C162847 | 48780-1 | f386c649-ce89-0266-e053-dadaa90a7c1a | Perrigo Loratadine Tablets, 10 mg Drug Facts |
| 66267-653-07 | 2023-01-30 | C162847 | 48780-1 | f386c649-ce89-0266-e053-dadaa90a7c1a | Perrigo Loratadine Tablets, 10 mg Drug Facts |
| 66267-653-10 | 2023-01-30 | C162847 | 48780-1 | f386c649-ce89-0266-e053-dadaa90a7c1a | Perrigo Loratadine Tablets, 10 mg Drug Facts |
| 66267-653-14 | 2023-01-30 | C162847 | 48780-1 | f386c649-ce89-0266-e053-dadaa90a7c1a | Perrigo Loratadine Tablets, 10 mg Drug Facts |
| 66267-653-20 | 2023-01-30 | C162847 | 48780-1 | f386c649-ce89-0266-e053-dadaa90a7c1a | Perrigo Loratadine Tablets, 10 mg Drug Facts |
| 66267-653-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-ce89-0266-e053-dadaa90a7c1a | Perrigo Loratadine Tablets, 10 mg Drug Facts |
| 66267-653-60 | 2023-01-30 | C162847 | 48780-1 | f386c649-ce89-0266-e053-dadaa90a7c1a | Perrigo Loratadine Tablets, 10 mg Drug Facts |
| 66267-653-90 | 2023-01-30 | C162847 | 48780-1 | f386c649-ce89-0266-e053-dadaa90a7c1a | Perrigo Loratadine Tablets, 10 mg Drug Facts |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66267-653-07 | Loratadineantihistamine | 7 in 1 BOTTLE | TABLET | 7 | | 6 |
| 66267-653-10 | Loratadineantihistamine | 10 in 1 BOTTLE | TABLET | 10 | | 6 |
| 66267-653-14 | Loratadineantihistamine | 14 in 1 BOTTLE | TABLET | 14 | | 6 |
| 66267-653-20 | Loratadineantihistamine | 20 in 1 BOTTLE | TABLET | 20 | | 6 |
| 66267-653-30 | Loratadineantihistamine | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 66267-653-60 | Loratadineantihistamine | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
| 66267-653-90 | Loratadineantihistamine | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66267-653 | LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [NUCARE PHARMACEUTICALS,INC.] | 6 | Current NDC, Legacy NDC, 7 package rows | 20250112_54b37bcc-a8b0-0c17-e054-00144ff8d46c.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 |
|---|
| 66267-653-07 | 66267065307 | 7 TABLET in 1 BOTTLE (66267-653-07) | 7 tablet | 2017-07-19 | 0000-00-00 | No | No | Current |
| 66267-653-10 | 66267065310 | 10 TABLET in 1 BOTTLE (66267-653-10) | 10 tablet | 2017-07-19 | 0000-00-00 | No | No | Current |
| 66267-653-14 | 66267065314 | 14 TABLET in 1 BOTTLE (66267-653-14) | 14 tablet | 2017-07-19 | 0000-00-00 | No | No | Current |
| 66267-653-20 | 66267065320 | 20 TABLET in 1 BOTTLE (66267-653-20) | 20 tablet | 2017-07-19 | 0000-00-00 | No | No | Current |
| 66267-653-30 | 66267065330 | 30 TABLET in 1 BOTTLE (66267-653-30) | 30 tablet | 2017-07-19 | 0000-00-00 | No | No | Current |
| 66267-653-60 | 66267065360 | 60 TABLET in 1 BOTTLE (66267-653-60) | 60 tablet | 2017-07-19 | 0000-00-00 | No | No | Current |
| 66267-653-90 | 66267065390 | 90 TABLET in 1 BOTTLE (66267-653-90) | 90 tablet | 2017-07-19 | 0000-00-00 | No | No | Current |