Acebutolol Hydrochloride
- Product NDC
- 53746-670
- 11-digit product format
- 537460670
- Labeler code
- 53746
- Product ID
- 53746-670_32106d1d-d15a-41e6-9e2a-57394e8ae558
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acebutolol Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA075047
- Marketing category
- ANDA
- Marketing start
- 2009-12-01
- 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 |
|---|
| 53746-670-01 | Acebutolol Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 7 |
| 53746-670-05 | Acebutolol Hydrochloride | 500 in 1 BOTTLE | CAPSULE | 500 | | 7 |
| 53746-670-30 | Acebutolol Hydrochloride | 30 in 1 BOTTLE | CAPSULE | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-670 | ACEBUTOLOL HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 7 | Current NDC, Legacy NDC, 3 package rows | 20250107_fe2cd5c0-ee16-4bcb-ad92-3755881dbe79.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 |
|---|
| 53746-670-01 | 53746067001 | 100 CAPSULE in 1 BOTTLE (53746-670-01) | 100 capsule | 2009-12-01 | 0000-00-00 | No | No | Current |
| 53746-670-05 | 53746067005 | 500 CAPSULE in 1 BOTTLE (53746-670-05) | 500 capsule | 2009-12-01 | 0000-00-00 | No | No | Current |
| 53746-670-30 | 53746067030 | 30 CAPSULE in 1 BOTTLE (53746-670-30) | 30 capsule | 2009-12-01 | 0000-00-00 | No | No | Current |