Acebutolol Hydrochloride
- Product NDC
- 62559-256
- 11-digit product format
- 625590256
- Labeler code
- 62559
- Product ID
- 62559-256_512c2032-4b9a-4b8c-b360-02f89d62714c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acebutolol Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA074007
- Marketing category
- ANDA
- Marketing start
- 2022-07-25
- Substance
- ACEBUTOLOL HYDROCHLORIDE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], 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
- Acebutolol Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACEBUTOLOL HYDROCHLORIDE | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | B025Y34C54 |
| Rxcui | 998685, 998689 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62559-256-01 | Acebutolol Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62559-256 | ACEBUTOLOL HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20230107_48bded12-09c7-47f2-b162-ec970a77f2d8.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 |
|---|
| 62559-256-01 | 62559025601 | 100 CAPSULE in 1 BOTTLE (62559-256-01) | 100 capsule | 2022-07-25 | 0000-00-00 | No | No | Current |