Carvedilol
- Product NDC
- 43063-126
- 11-digit product format
- 430630126
- Labeler code
- 43063
- Product ID
- 43063-126_41376da3-5277-b133-e063-6394a90afa13
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carvedilol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078332
- Marketing category
- ANDA
- Marketing start
- 2007-09-05
- Substance
- CARVEDILOL
- Active strength
- 3.125 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Carvedilol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARVEDILOL | 3.125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0K47UL67F2 |
| Rxcui | 686924 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-126-60 | Carvedilol | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 27 |
| 43063-126-93 | Carvedilol | 180 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 180 | | 27 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CARVEDILOL | ACTIVE INGREDIENT | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| CARVEDILOL | ACTIVE MOIETY | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 14 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 14 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-126 | CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 26 | Current NDC, Legacy NDC, 2 package rows | 20240809_8640adde-d071-44a4-97d0-fa8a8548debe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-126-60 | 43063012660 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-126-60) | 2013-10-30 | 0000-00-00 | No | No | Current |
| 43063-126-93 | 43063012693 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-126-93) | 2013-10-30 | 0000-00-00 | No | No | Current |