Carvedilol
- Product NDC
- 68382-094
- 11-digit product format
- 683820094
- Labeler code
- 68382
- Product ID
- 68382-094_a7e5dd69-ac10-4f36-a366-4ddc1426aef1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carvedilol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA077614
- Marketing category
- ANDA
- Marketing start
- 2007-09-05
- Substance
- CARVEDILOL
- Active strength
- 12.5 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Carvedilol
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARVEDILOL | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0K47UL67F2 |
| Rxcui | 200031, 200032, 200033, 686924 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-094-01 | Carvedilol | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 16 |
| 68382-094-05 | Carvedilol | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 16 |
| 68382-094-17 | Carvedilol | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CARVEDILOL | ACTIVE INGREDIENT | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| CARVEDILOL | ACTIVE MOIETY | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| AMINOLEVULINIC ACID HYDROCHLORIDE | INACTIVE INGREDIENT | V35KBM8JGR | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| AMINOMETRADINE | INACTIVE INGREDIENT | PPM8SX5Q3V | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| AMINOPENTAMIDE SULFATE | INACTIVE INGREDIENT | 20P9NI883O | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| AMINOPHYLLINE | INACTIVE INGREDIENT | 27Y3KJK423 | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| AMINOPROMAZINE | INACTIVE INGREDIENT | S9SDD93U5U | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| AMINOPROPAZINE FUMARATE | INACTIVE INGREDIENT | 9KWA4W69IW | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| AMINOPTERIN SODIUM | INACTIVE INGREDIENT | FZU1QI13O9 | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| AMMI VISNAGA FRUIT | INACTIVE INGREDIENT | 3UN285QN0C | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| AMOPROXAN | INACTIVE INGREDIENT | 27RL57FCYM | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| CARVEDILOL | ACTIVE INGREDIENT | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CARVEDILOL | ACTIVE MOIETY | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-094 | CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] | 15 | Current NDC, Legacy NDC, 3 package rows | 20231216_dc6a2d33-aa04-4a04-9cde-901b744d24ca.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 |
|---|
| 68382-094-01 | 68382009401 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-094-01) | 2007-09-05 | 0000-00-00 | No | No | Current |
| 68382-094-05 | 68382009405 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-094-05) | 2007-09-05 | 0000-00-00 | No | No | Current |
| 68382-094-17 | 68382009417 | 28 TABLET, FILM COATED in 1 BOTTLE (68382-094-17) | 2007-09-05 | 0000-00-00 | No | No | Current |