topcare childrens allergy relief
- Product NDC
- 36800-363
- 11-digit product format
- 368000363
- Labeler code
- 36800
- Product ID
- 36800-363_d6a8c36e-4c50-4c16-96a0-2b056a050e17
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- loratadine
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA210033
- Marketing category
- ANDA
- Marketing start
- 2019-09-20
- Substance
- LORATADINE
- Active strength
- 5 mg/1
- 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 relief
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LORATADINE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 665078 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-363-39 | topcare childrens allergy relief | 1 in 1 BLISTER PACK | TABLET, CHEWABLE | 1 | | 4 |
| 36800-363-39 | topcare childrens allergy relief | 30 in 1 CARTON | TABLET, CHEWABLE | 30 | | 4 |
| 36800-363-49 | topcare childrens allergy relief | 1 in 1 BLISTER PACK | TABLET, CHEWABLE | 1 | | 4 |
| 36800-363-49 | topcare childrens allergy relief | 40 in 1 CARTON | TABLET, CHEWABLE | 40 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-363 | TOPCARE CHILDRENS ALLERGY RELIEF (LORATADINE) TABLET, CHEWABLE [TOPCO ASSOCIATES LLC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20230625_4f7555ea-6286-4ff6-b125-d12660ae4bdf.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 |
|---|
| 36800-363-39 | 36800036339 | 30 BLISTER PACK in 1 CARTON (36800-363-39) / 1 TABLET, CHEWABLE in 1 BLISTER PACK | 30 blister pack | 2019-09-20 | 0000-00-00 | No | No | Current |
| 36800-363-49 | 36800036349 | 40 BLISTER PACK in 1 CARTON (36800-363-49) / 1 TABLET, CHEWABLE in 1 BLISTER PACK | 40 blister pack | 2023-06-20 | | No | No | Current |