topcare allergy and congestion relief
- Product NDC
- 36800-611
- 11-digit product format
- 368000611
- Labeler code
- 36800
- Product ID
- 36800-611_47f02151-689c-4592-ab13-6c4e259d7a6c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- loratadine, pseudoephedrine sulfate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA076050
- Marketing category
- ANDA
- Marketing start
- 2018-05-18
- Substance
- LORATADINE; PSEUDOEPHEDRINE SULFATE
- Active strength
- 5; 120 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- 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 and congestion relief
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LORATADINE | 5 mg/1 |
| PSEUDOEPHEDRINE SULFATE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN, Y9DL7QPE6B |
| Rxcui | 1242399 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-611-65 | topcare allergy and congestion relief | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 6 |
| 36800-611-65 | topcare allergy and congestion relief | 30 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-611 | TOPCARE ALLERGY AND CONGESTION RELIEF (LORATADINE, PSEUDOEPHEDRINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20220219_dd93d172-2a3a-4e4c-a237-7668acbd537d.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 |
|---|
| 36800-611-65 | 36800061165 | 30 BLISTER PACK in 1 CARTON (36800-611-65) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 30 blister pack | 2018-05-18 | 0000-00-00 | No | No | Current |