SECTRAL
- Product NDC
- 67857-701
- 11-digit product format
- 678570701
- Labeler code
- 67857
- Product ID
- 67857-701_8d674ec6-61e4-41f2-91f8-4a0df9c141b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acebutolol hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Promius Pharma, LLC
- Application
- NDA018917
- Marketing category
- NDA
- Marketing start
- 1984-12-28
- 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
- E
- Listing certified through
- 2018-12-31
- 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 |
|---|
| 67857-701-01 | SECTRAL | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACEBUTOLOL HYDROCHLORIDE | ACTIVE INGREDIENT | B025Y34C54 | SECTRAL (ACEBUTOLOL HYDROCHLORIDE) CAPSULE [PROMIUS PHARMA, LLC] | 1 | |
| ACEBUTOLOL | ACTIVE MOIETY | 67P356D8GH | SECTRAL (ACEBUTOLOL HYDROCHLORIDE) CAPSULE [PROMIUS PHARMA, LLC] | 1 | |
| D&C Red No. 22 | INACTIVE INGREDIENT | 1678RKX8RT | SECTRAL (ACEBUTOLOL HYDROCHLORIDE) CAPSULE [PROMIUS PHARMA, LLC] | 1 | |
| D&C Red No. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | SECTRAL (ACEBUTOLOL HYDROCHLORIDE) CAPSULE [PROMIUS PHARMA, LLC] | 1 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | SECTRAL (ACEBUTOLOL HYDROCHLORIDE) CAPSULE [PROMIUS PHARMA, LLC] | 1 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | SECTRAL (ACEBUTOLOL HYDROCHLORIDE) CAPSULE [PROMIUS PHARMA, LLC] | 1 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | SECTRAL (ACEBUTOLOL HYDROCHLORIDE) CAPSULE [PROMIUS PHARMA, LLC] | 1 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | SECTRAL (ACEBUTOLOL HYDROCHLORIDE) CAPSULE [PROMIUS PHARMA, LLC] | 1 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | SECTRAL (ACEBUTOLOL HYDROCHLORIDE) CAPSULE [PROMIUS PHARMA, LLC] | 1 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | SECTRAL (ACEBUTOLOL HYDROCHLORIDE) CAPSULE [PROMIUS PHARMA, LLC] | 1 | |
| stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | SECTRAL (ACEBUTOLOL HYDROCHLORIDE) CAPSULE [PROMIUS PHARMA, LLC] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | SECTRAL (ACEBUTOLOL HYDROCHLORIDE) CAPSULE [PROMIUS PHARMA, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67857-701 | SECTRAL (ACEBUTOLOL HYDROCHLORIDE) CAPSULE [PROMIUS PHARMA, LLC] | 1 | Legacy NDC, 1 package rows | 20120131_7eee95bf-0452-4d6e-9712-33403768695a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 67857-701-01 | 67857070101 | 100 in 1 BOTTLE, PLASTIC | Historical |