CODEINE AND CHLORPHENIRAMINE MALEATE ER
- Product NDC
- 0722-7184
- 11-digit product format
- 007227184
- Labeler code
- 0722
- Product ID
- 0722-7184_6feb059d-5153-42a5-9306-6b05429ca86d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CODEINE AND CHLORPHENIRAMINE MALEATE ER
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Nexgen Pharma, Inc.
- Application
- NDA206323
- Marketing category
- NDA
- Marketing start
- 2015-09-01
- Marketing end
- 0000-00-00
- Substance
- CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE
- Active strength
- 54 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0722-7184-01 | CODEINE AND CHLORPHENIRAMINE MALEATE ER | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CHLORPHENIRAMINE MALEATE | ACTIVE INGREDIENT | V1Q0O9OJ9Z | CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.] | 1 | |
| CODEINE PHOSPHATE | ACTIVE INGREDIENT | GSL05Y1MN6 | CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.] | 1 | |
| CHLORPHENIRAMINE | ACTIVE MOIETY | 3U6IO1965U | CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.] | 1 | |
| CODEINE ANHYDROUS | ACTIVE MOIETY | UX6OWY2V7J | CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.] | 1 | |
| HYPROMELLOSE 2208 (4000 MPA.S) | INACTIVE INGREDIENT | 39J80LT57T | CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0722-7184 | CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.] | 7 | Legacy NDC, 1 package rows | 20170210_f3114cff-d638-4562-9e11-88130677363c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 0722-7184-01 | 00722718401 | 100 in 1 BOTTLE | Historical |