Loratadine
- Product NDC
- 50436-3501
- 11-digit product format
- 504363501
- Labeler code
- 50436
- Product ID
- 50436-3501_cba498ce-6f23-44b4-82e4-dc1c7074369d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA076301
- Marketing category
- ANDA
- Marketing start
- 2008-10-15
- 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 |
|---|---|---|---|---|---|
| 50436-3501-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d8c8-f424-e053-dadaa90a57ce | Perrigo Loratadine Tablets, 10 mg Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-3501-2 | Loratadine antihistamine | 30 in 1 BOTTLE | TABLET | 30 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-3501-2 | EA - Each | 50436-3501 | bb7c2a0f-3f50-4b1f-b27d-2e29075c6bdd | 1 | 2014-12-01 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LORATADINE | ACTIVE INGREDIENT | 7AJO3BO7QN | LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [UNIT DOSE SERVICES] | 2 | |
| LORATADINE | ACTIVE MOIETY | 7AJO3BO7QN | LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [UNIT DOSE SERVICES] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [UNIT DOSE SERVICES] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [UNIT DOSE SERVICES] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [UNIT DOSE SERVICES] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [UNIT DOSE SERVICES] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-3501 | LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [UNIT DOSE SERVICES] | 2 | Legacy NDC, 1 package rows | 20130522_a11b1e64-d4aa-4a5d-84fa-85b4b133de71.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311372 | loratadine 10 MG 24HR Oral Tablet | PSN | a11b1e64-d4aa-4a5d-84fa-85b4b133de71 | 2 |
| 311372 | loratadine 10 MG Oral Tablet | SCD | a11b1e64-d4aa-4a5d-84fa-85b4b133de71 | 2 |
| 311372 | loratadine 10 MG 24 HR Oral Tablet | SY | a11b1e64-d4aa-4a5d-84fa-85b4b133de71 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-3501-2 | 50436350102 | 30 in 1 BOTTLE | Historical |