Childrens Loratadine
- Product NDC
- 51672-2092
- 11-digit product format
- 516722092
- Labeler code
- 51672
- Product ID
- 51672-2092_a032a1a9-e0ce-4176-8479-75263c601d65
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Taro Pharmaceuticals U.S.A., Inc.
- Application
- ANDA076805
- Marketing category
- ANDA
- Marketing start
- 2010-02-27
- Marketing end
- 0000-00-00
- Substance
- LORATADINE
- Active strength
- 5 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Loratadine | ACTIVE INGREDIENT | 7AJO3BO7QN | CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| Loratadine | ACTIVE MOIETY | 7AJO3BO7QN | CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| phosphoric acid | INACTIVE INGREDIENT | E4GA8884NN | CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| sodium metabisulfite | INACTIVE INGREDIENT | 4VON5FNS3C | CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| sodium phosphate, monobasic, dihydrate | INACTIVE INGREDIENT | 5QWK665956 | CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-2092 | CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 6 | Legacy NDC | 20241222_c4d05a9a-3765-4144-803e-462712bf3772.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51672-2092-1 | 51672209201 | 1 BOTTLE in 1 CARTON (51672-2092-1) > 240 mL in 1 BOTTLE | 1 bottle | 2010-02-27 | 0000-00-00 | No | No | Current |
| 51672-2092-4 | 51672209204 | 1 BOTTLE in 1 CARTON (51672-2092-4) > 60 mL in 1 BOTTLE | 1 bottle | 2010-02-27 | 0000-00-00 | No | No | Current |
| 51672-2092-8 | 51672209208 | 1 BOTTLE in 1 CARTON (51672-2092-8) > 120 mL in 1 BOTTLE | 1 bottle | 2010-02-27 | 0000-00-00 | No | No | Current |