FDA.reportPublic FDA data

Dexbrompherniramine Maleate and Pseudoephedrine Sulfate

Product NDC
10702-005
11-digit product format
107020005
Labeler code
10702
Product ID
10702-005_838e40fd-bd38-4b8d-abd4-45da435f1777
Type
HUMAN OTC DRUG
Nonproprietary name
Dexbrompherniramine Maleate and Pseudoephedrine Sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
KVK-TECH, INC.
Application
ANDA078648
Marketing category
ANDA
Marketing start
2018-12-17
Marketing end
0000-00-00
Substance
DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
Active strength
6 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10702-005DDiscontinued by firm2026-07-31
excluded packagepackage10702-00510702-005-03DDiscontinued by firm2026-07-31
excluded packagepackage10702-00510702-005-21DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078648-001DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATEDEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE6MG;120MGTABLET, EXTENDED RELEASE / ORAL2013-02-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078648-001DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE6MG;120MGTABLET, EXTENDED RELEASE / ORAL2013-02-27a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXBROMPHENIRAMINE MALEATEACTIVE INGREDIENTBPA9UT29BSDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
PSEUDOEPHEDRINE SULFATEACTIVE INGREDIENTY9DL7QPE6BDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
DEXBROMPHENIRAMINEACTIVE MOIETY75T64B71RPDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-005DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]4Legacy NDC20181217_cc1c8c6b-66a4-4d2d-88b2-02ad3591a0f4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-005-031070200050330 TABLET, EXTENDED RELEASE in 1 BOTTLE (10702-005-03) 2018-12-170000-00-00NoNoCurrent
10702-005-21107020005212 BLISTER PACK in 1 CARTON (10702-005-21) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2018-12-170000-00-00NoNoCurrent