Carvedilol
- Product NDC
- 0904-6303
- 11-digit product format
- 009046303
- Labeler code
- 0904
- Product ID
- 0904-6303_c519a97b-5893-4a94-9923-1f867d08bdf1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carvedilol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA078227
- Marketing category
- ANDA
- Marketing start
- 2012-11-14
- Marketing end
- 0000-00-00
- Substance
- CARVEDILOL
- Active strength
- 25 mg/1
- Pharmacologic classes
- Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]
- 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 |
|---|
| CARVEDILOL | ACTIVE INGREDIENT | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| CARVEDILOL | ACTIVE MOIETY | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| POVIDONE K12 | INACTIVE INGREDIENT | 333AG72FWJ | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6303 | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 11 | Legacy NDC | 20241122_d5a28e57-7304-4e23-98a3-bae14d8ed25f.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-6303-61 | 00904630361 | 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0904-6303-61) | 2012-11-14 | 0000-00-00 | No | No | Current |