Loratadine
- Product NDC
- 59564-251
- 11-digit product format
- 595640251
- Labeler code
- 59564
- Product ID
- 59564-251_603b96bf-ab3f-4ac2-966b-8060f1cfe745
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Innovative Manufacturing and Distribution Services, Inc.
- Application
- ANDA076134
- Marketing category
- ANDA
- Marketing start
- 2008-12-01
- Marketing end
- 0000-00-00
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59564-251-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-cd9a-f424-e053-dadaa90a57ce | Drug Facts |
| 59564-251-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-cd9a-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59564-251-10 | Loratadine | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 59564-251-30 | Loratadine | 100 in 1 BOTTLE | TABLET | 100 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59564-251-10 | EA - Each | 59564-251 | 8f37b259-9af1-435e-9120-c6c88c01fb21 | 1 | 2018-01-12 |
| 59564-251-30 | EA - Each | 59564-251 | a4695d38-70a1-4776-9204-0434501f8d9d | 1 | 2018-01-12 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LORATADINE | ACTIVE INGREDIENT | 7AJO3BO7QN | LORATADINE TABLET [INNOVATIVE MANUFACTURING AND DISTRIBUTION SERVICES, INC.] | 1 | |
| LORATADINE | ACTIVE MOIETY | 7AJO3BO7QN | LORATADINE TABLET [INNOVATIVE MANUFACTURING AND DISTRIBUTION SERVICES, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LORATADINE TABLET [INNOVATIVE MANUFACTURING AND DISTRIBUTION SERVICES, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LORATADINE TABLET [INNOVATIVE MANUFACTURING AND DISTRIBUTION SERVICES, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LORATADINE TABLET [INNOVATIVE MANUFACTURING AND DISTRIBUTION SERVICES, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | LORATADINE TABLET [INNOVATIVE MANUFACTURING AND DISTRIBUTION SERVICES, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311372 | loratadine 10 MG 24HR Oral Tablet | PSN | 603b96bf-ab3f-4ac2-966b-8060f1cfe745 | 1 |
| 311372 | loratadine 10 MG Oral Tablet | SCD | 603b96bf-ab3f-4ac2-966b-8060f1cfe745 | 1 |
| 311372 | loratadine 10 MG 24 HR Oral Tablet | SY | 603b96bf-ab3f-4ac2-966b-8060f1cfe745 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 59564-251-10 | 59564025110 | 30 in 1 BOTTLE | Historical |
| 59564-251-30 | 59564025130 | 100 in 1 BOTTLE | Historical |