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
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DEXBROMPHENIRAMINE MALEATE | ACTIVE INGREDIENT | BPA9UT29BS | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| PSEUDOEPHEDRINE SULFATE | ACTIVE INGREDIENT | Y9DL7QPE6B | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| DEXBROMPHENIRAMINE | ACTIVE MOIETY | 75T64B71RP | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| CALCIUM SULFATE | INACTIVE INGREDIENT | WAT0DDB505 | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DEXBROMPHERNIRAMINE 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 INGREDIENT | 74G4R6TH13 | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 2 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | DEXBROMPHERNIRAMINE 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| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10702-005 | DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.] | 4 | Legacy NDC | 20181217_cc1c8c6b-66a4-4d2d-88b2-02ad3591a0f4.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 10702-005-03 | 10702000503 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10702-005-03) | | 2018-12-17 | 0000-00-00 | No | No | Current |
| 10702-005-21 | 10702000521 | 2 BLISTER PACK in 1 CARTON (10702-005-21) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2018-12-17 | 0000-00-00 | No | No | Current |