Loratadine
- Product NDC
- 60505-0147
- 11-digit product format
- 605050147
- Labeler code
- 60505
- Product ID
- 60505-0147_c15c5b51-bc6a-e99e-e5e7-52e61c5da7b0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA076471
- Marketing category
- ANDA
- Marketing start
- 2005-01-24
- 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 |
|---|
| 60505-0147-1 | Loratadine | 100 in 1 BOTTLE | TABLET | 100 | | 9 |
| 60505-0147-8 | Loratadine | 1000 in 1 BOTTLE | TABLET | 1000 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LORATADINE | ACTIVE INGREDIENT | 7AJO3BO7QN | LORATADINE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| LORATADINE | ACTIVE INGREDIENT | 7AJO3BO7QN | LORATADINE TABLET [APOTEX CORP.] | 1 | |
| LORATADINE | ACTIVE MOIETY | 7AJO3BO7QN | LORATADINE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| LORATADINE | ACTIVE MOIETY | 7AJO3BO7QN | LORATADINE TABLET [APOTEX CORP.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LORATADINE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LORATADINE TABLET [APOTEX CORP.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LORATADINE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LORATADINE TABLET [APOTEX CORP.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LORATADINE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LORATADINE TABLET [APOTEX CORP.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LORATADINE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LORATADINE TABLET [APOTEX CORP.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LORATADINE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LORATADINE TABLET [APOTEX CORP.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-0147 | LORATADINE TABLET [APOTEX CORP.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240927_679164cc-7505-7ed4-13fe-87f06cb777d8.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 |
|---|
| 60505-0147-1 | 60505014701 | 100 TABLET in 1 BOTTLE (60505-0147-1) | 100 tablet | 2005-01-24 | 2022-06-30 | No | No | Current |
| 60505-0147-8 | 60505014708 | 1000 TABLET in 1 BOTTLE (60505-0147-8) | 1000 tablet | 2005-01-24 | 0000-00-00 | No | No | Current |