Carvedilol
- Product NDC
- 0615-8389
- 11-digit product format
- 006158389
- Labeler code
- 0615
- Product ID
- 0615-8389_d801a448-2fce-468f-8377-1271eeebba96
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carvedilol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA076373
- Marketing category
- ANDA
- Marketing start
- 2007-09-06
- 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
- 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 | 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 |
|---|
| 0615-8389-30 | Carvedilol | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | | 8 |
| 0615-8389-30 | Carvedilol | 6 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 6 | | 8 |
| 0615-8389-39 | Carvedilol | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8389 | CARVEDILOL TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 7 | Current NDC, Legacy NDC, 3 package rows | 20240919_2fb46fe1-9b7b-4718-9327-2471af22f0b7.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 |
|---|
| 0615-8389-30 | 00615838930 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8389-30) > 5 TABLET, FILM COATED in 1 BLISTER PACK | 6 blister pack | 2021-02-10 | 0000-00-00 | No | No | Current |
| 0615-8389-39 | 00615838939 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8389-39) | | 2021-02-19 | 0000-00-00 | No | No | Current |