Chlorphen-12
- Product NDC
- 10702-017
- 11-digit product format
- 107020017
- Labeler code
- 10702
- Product ID
- 10702-017_7d67f785-a25f-1819-e053-2991aa0a11d3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Chlorpheniramine Maleate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- KVK-Tech, Inc.
- Application
- ANDA040829
- Marketing category
- ANDA
- Marketing start
- 2010-06-15
- Substance
- CHLORPHENIRAMINE MALEATE
- Active strength
- 12 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Chlorphen-12
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHLORPHENIRAMINE MALEATE | 12 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V1Q0O9OJ9Z |
| Rxcui | 1363288 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10702-017-01 | Chlorphen-12 | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 4 |
| 10702-017-04 | Chlorphen-12 | 4 in 1 PACKAGE | TABLET, FILM COATED, EXTENDED RE | 4 | | 4 |
| 10702-017-06 | Chlorphen-12 | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 4 |
| 10702-017-24 | Chlorphen-12 | 24 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 24 | | 4 |
| 10702-017-54 | Chlorphen-12 | 50 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 50 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CHLORPHENIRAMINE MALEATE | ACTIVE INGREDIENT | V1Q0O9OJ9Z | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| CHLORPHENIRAMINE | ACTIVE MOIETY | 3U6IO1965U | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| CALCIUM SULFATE | INACTIVE INGREDIENT | WAT0DDB505 | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| SODIUM LAURETH SULFATE | INACTIVE INGREDIENT | BPV390UAP0 | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10702-017 | CHLORPHEN-12 (CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.] | 4 | Current NDC, Legacy NDC, 5 package rows | 20181220_84409269-fe9b-469e-9a66-27b1475231a3.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 |
|---|
| 10702-017-01 | 10702001701 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10702-017-01) | | 2010-06-15 | 0000-00-00 | No | No | Current |
| 10702-017-04 | 10702001704 | 4 in 1 PACKAGE | | | | | | Historical |
| 10702-017-06 | 10702001706 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10702-017-06) | | 2010-06-15 | 0000-00-00 | No | No | Current |
| 10702-017-24 | 10702001724 | 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (10702-017-24) | | 2010-06-15 | 0000-00-00 | No | No | Current |
| 10702-017-54 | 10702001754 | 50 PACKAGE in 1 CARTON (10702-017-54) / 4 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (10702-017-04) | 50 package | 2018-11-29 | 0000-00-00 | No | No | Current |