Carbinoxamine Maleate
- Product NDC
- 51991-333
- 11-digit product format
- 519910333
- Labeler code
- 51991
- Product ID
- 51991-333_e95a03c6-f423-7177-e053-2a95a90a0add
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- carbinoxamine maleate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA040442
- Marketing category
- ANDA
- Marketing start
- 2012-12-10
- Marketing end
- 2025-06-09
- Substance
- CARBINOXAMINE MALEATE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CARBINOXAMINE MALEATE | ACTIVE INGREDIENT | 02O55696WH | CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] | 2 | |
| CARBINOXAMINE | ACTIVE MOIETY | 982A7M02H5 | CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] | 2 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] | 2 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] | 2 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51991-333 | CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] | 8 | Legacy NDC | 20220924_1edca669-8879-408a-b09c-259e363dd95c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51991-333-01 | 51991033301 | 100 TABLET in 1 BOTTLE, PLASTIC (51991-333-01) | 100 tablet | 2012-12-10 | 0000-00-00 | No | No | Current |