Carvedilol
- Product NDC
- 68084-854
- 11-digit product format
- 680840854
- Labeler code
- 68084
- Product ID
- 68084-854_2e949f24-e7de-0a5d-e063-6394a90a97d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carvedilol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA077614
- Marketing category
- ANDA
- Marketing start
- 2015-05-04
- Substance
- CARVEDILOL
- Active strength
- 6.25 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
- 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 | 6.25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0K47UL67F2 |
| Rxcui | 200031 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-854-01 | Carvedilol | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | | 10 |
| 68084-854-11 | Carvedilol | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CARVEDILOL | ACTIVE INGREDIENT | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| CARVEDILOL | ACTIVE MOIETY | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-854 | CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250223_a97a2467-7525-467c-8969-38246903690c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68084-854-01 | 68084085401 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-854-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-854-11) | 100 blister pack | 2015-05-04 | 0000-00-00 | No | No | Current |
| 68084-854-11 | 68084085411 | 1 in 1 BLISTER PACK | | | | | | Historical |