topcare childrens allergy
- Product NDC
- 36800-608
- 11-digit product format
- 368000608
- Labeler code
- 36800
- Product ID
- 36800-608_3e49bf56-baef-4c33-a38b-a25794c15622
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- loratadine
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA075728
- Marketing category
- ANDA
- Marketing start
- 2020-07-08
- Substance
- LORATADINE
- Active strength
- 5 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- topcare childrens allergy
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LORATADINE | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 692783 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-608-26 | topcare childrens allergy | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
| 36800-608-26 | topcare childrens allergy | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-608 | TOPCARE CHILDRENS ALLERGY (LORATADINE) SOLUTION [TOPCO ASSOCIATES LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20220318_6e175fae-05dd-45c2-b9ab-7d49369a3c05.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 36800-608-26 | 36800060826 | 1 BOTTLE in 1 CARTON (36800-608-26) / 120 mL in 1 BOTTLE | 1 bottle | 2020-07-08 | 0000-00-00 | No | No | Current |