Topcare Allergy Relief
- Product NDC
- 36800-853
- 11-digit product format
- 368000853
- Labeler code
- 36800
- Product ID
- 36800-853_4bd57bff-c68b-497f-801d-e60d9c7b8390
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- loratadine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA076011
- Marketing category
- ANDA
- Marketing start
- 2020-06-25
- Substance
- LORATADINE
- Active strength
- 10 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 Allergy Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LORATADINE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 311373 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-853-65 | Topcare Allergy Relief | 30 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 30 | | 3 |
| 36800-853-65 | Topcare Allergy Relief | 1 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-853 | TOPCARE ALLERGY RELIEF (LORATADINE) TABLET, ORALLY DISINTEGRATING [TOPCO ASSOCIATES LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20211202_32f4e1d1-c830-4752-8251-bcc233bf03f6.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 |
|---|
| 36800-853-65 | 36800085365 | 30 BLISTER PACK in 1 CARTON (36800-853-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 30 blister pack | 2020-06-25 | 0000-00-00 | No | No | Current |