Carvedilol
- Product NDC
- 68645-351
- 11-digit product format
- 686450351
- Labeler code
- 68645
- Product ID
- 68645-351_b4f2d5cd-dc9b-9d8c-e053-2995a90a02d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carvedilol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Legacy Pharmaceutical Packaging, LLC
- Application
- ANDA077614
- Marketing category
- ANDA
- Marketing start
- 2007-09-05
- Marketing end
- 0000-00-00
- Substance
- CARVEDILOL
- Active strength
- 13 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CARVEDILOL | ACTIVE INGREDIENT | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] | 2 | |
| CARVEDILOL | ACTIVE MOIETY | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68645-351 | CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 13 | Legacy NDC | 20241012_0db9d532-d62c-46c5-b4b9-855d78d01314.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68645-351-59 | 68645035159 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68645-351-59) | 2007-09-05 | 0000-00-00 | No | No | Current |