Loratadine
- Product NDC
- 15127-715
- 11-digit product format
- 151270715
- Labeler code
- 15127
- Product ID
- 15127-715_73e2a4b3-c024-4b6a-8a92-519df6c3f202
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Select Brand
- Application
- ANDA076134
- Marketing category
- ANDA
- Marketing start
- 2003-08-19
- Marketing end
- 0000-00-00
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 15127-715-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-16b3-f424-e053-dadaa90a57ce | Drug Facts |
| 15127-715-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-16b3-f424-e053-dadaa90a57ce | Drug Facts |
| 15127-715-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-16b3-f424-e053-dadaa90a57ce | Drug Facts |
| 15127-715-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-16b3-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 15127-715-01 | Loratadine | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 15127-715-10 | Loratadine | 10 in 1 BLISTER PACK | TABLET | 10 | 1 | |
| 15127-715-30 | Loratadine | 30 in 1 BLISTER PACK | TABLET | 30 | 1 | |
| 15127-715-60 | Loratadine | 60 in 1 BOTTLE | TABLET | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 15127-715-01 | EA - Each | 15127-715 | b0c8885f-00b9-47d3-9474-87f310a70ada | 1 | 2013-02-13 |
| 15127-715-10 | EA - Each | 15127-715 | 416a5c3c-048e-48cc-b491-d54f8e0acf86 | 1 | 2013-02-13 |
| 15127-715-30 | EA - Each | 15127-715 | 577a521f-42c8-4a0b-bd95-56969710d263 | 1 | 2013-02-13 |
| 15127-715-60 | EA - Each | 15127-715 | 44b20392-b5cf-4544-b2b5-5fd49e2a312c | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LORATADINE | ACTIVE INGREDIENT | 7AJO3BO7QN | LORATADINE TABLET [SELECT BRAND] | 1 | |
| LORATADINE | ACTIVE MOIETY | 7AJO3BO7QN | LORATADINE TABLET [SELECT BRAND] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LORATADINE TABLET [SELECT BRAND] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LORATADINE TABLET [SELECT BRAND] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LORATADINE TABLET [SELECT BRAND] | 1 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | LORATADINE TABLET [SELECT BRAND] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311372 | loratadine 10 MG 24HR Oral Tablet | PSN | 14c00a0a-3522-4f11-b409-8b1dcd18798e | 1 |
| 311372 | loratadine 10 MG Oral Tablet | SCD | 14c00a0a-3522-4f11-b409-8b1dcd18798e | 1 |
| 311372 | loratadine 10 MG 24 HR Oral Tablet | SY | 14c00a0a-3522-4f11-b409-8b1dcd18798e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 15127-715-01 | 15127071501 | 100 in 1 BOTTLE | Historical |
| 15127-715-10 | 15127071510 | 10 in 1 BLISTER PACK | Historical |
| 15127-715-30 | 15127071530 | 30 in 1 BLISTER PACK | Historical |
| 15127-715-60 | 15127071560 | 60 in 1 BOTTLE | Historical |