Acebutolol Hydrochloride
- Product NDC
- 10135-631
- 11-digit product format
- 101350631
- Labeler code
- 10135
- Product ID
- 10135-631_cbe8fc7a-1138-07d3-e053-2995a90ab572
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acebutolol Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals Inc
- Application
- ANDA075047
- Marketing category
- ANDA
- Marketing start
- 2017-10-20
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-631-01 | 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 |
|---|
| 10135-631 | ACEBUTOLOL HYDROCHLORIDE CAPSULE [MARLEX PHARMACEUTICALS INC] | 6 | Legacy NDC, 1 package rows | 20210915_1620c4d3-6a6e-49be-b002-8e4358b0c7d6.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 |
|---|
| 10135-631-01 | 10135063101 | 100 CAPSULE in 1 BOTTLE (10135-631-01) | 100 capsule | 2017-10-20 | 0000-00-00 | No | No | Current |