topcare allergy and congestion relief

Product NDC
36800-706
11-digit product format
368000706
Labeler code
36800
Product ID
36800-706_790d8277-d9af-46bb-ae3a-dfbf49b3d1be
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine, pseudoephedrine sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA075989
Marketing category
ANDA
Marketing start
2023-08-16
Substance
LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength
10; 240 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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
7AJO3BO7QNLORATADINE79794-75-5LORATADINE
Y9DL7QPE6BPSEUDOEPHEDRINE SULFATE7460-12-0PSEUDOEPHEDRINE SULFATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
36800-706-223680007062215 BLISTER PACK in 1 CARTON (36800-706-22) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK15 blister pack2023-08-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Topco Associates LLC. Allergy & Congestion Relief Drug FactsTopco Associates LLC2023-08-29HUMAN OTC DRUG LABEL2