Acebutolol Hydrochloride
- Product NDC
- 42291-010
- 11-digit product format
- 422910010
- Labeler code
- 42291
- Product ID
- 42291-010_48481cfc-a410-bc0a-e063-6294a90a7baf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acebutolol Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA075047
- Marketing category
- ANDA
- Marketing start
- 2023-04-26
- Substance
- ACEBUTOLOL HYDROCHLORIDE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], 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
- Acebutolol Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACEBUTOLOL HYDROCHLORIDE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | B025Y34C54 |
| Rxcui | 998689 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-010-01 | Acebutolol Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-010 | ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE] | 1 | Current NDC, 1 package rows | 20230427_fa40a564-a579-15c1-e053-6294a90ad8e9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42291-010-01 | 42291001001 | 100 CAPSULE in 1 BOTTLE (42291-010-01) | 100 capsule | 2023-04-26 | No | No | Current |