Loratadine
- Product NDC
- 21695-498
- 11-digit product format
- 216950498
- Labeler code
- 21695
- Product ID
- 21695-498_32f9efb1-3ab9-4d3c-a3b3-fd94874bea98
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA076805
- Marketing category
- ANDA
- Marketing start
- 2004-08-20
- Marketing end
- 0000-00-00
- Substance
- LORATADINE
- Active strength
- 5 mg/5mL
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-498-04 | 2019-09-24 | C162847 | 48780-1 | 934fe258-49f8-48b1-e053-8cdaa90a720a | Loratadine Syrup |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-498-04 | Loratadine | 120 mL in 1 BOTTLE | SOLUTION | 120 | 1 | |
| 21695-498-04 | Loratadine | 1 in 1 CARTON | SOLUTION | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-498-04 | ML - Milliliter | 21695-498 | a4ee976a-4886-47dd-adef-b43f0c2d55aa | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Loratadine | ACTIVE INGREDIENT | 7AJO3BO7QN | LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| Loratadine | ACTIVE MOIETY | 7AJO3BO7QN | LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| citric acid monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| sodium metabisulfite | INACTIVE INGREDIENT | 4VON5FNS3C | LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 692783 | loratadine 5 MG in 5 mL Oral Solution | PSN | 32f9efb1-3ab9-4d3c-a3b3-fd94874bea98 | 1 |
| 692783 | loratadine 1 MG/ML Oral Solution | SCD | 32f9efb1-3ab9-4d3c-a3b3-fd94874bea98 | 1 |
| 692783 | loratadine 5 MG per 5 ML Oral Solution | SY | 32f9efb1-3ab9-4d3c-a3b3-fd94874bea98 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-498-04 | 21695049804 | 120 mL in 1 BOTTLE | 120 ml | Historical |