Labetalol Hydrochloride
- Product NDC
- 68258-6047
- 11-digit product format
- 682586047
- Labeler code
- 68258
- Product ID
- 68258-6047_85ac20d9-9737-449c-9929-e84c649f5a00
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dispensing Solutions, Inc.
- Application
- ANDA074787
- Marketing category
- ANDA
- Marketing start
- 2011-01-01
- Marketing end
- 0000-00-00
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 68258-6047-3 | Labetalol Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 68258-6047-9 | Labetalol Hydrochloride | 90 in 1 PACKAGE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Labetalol Hydrochloride | ACTIVE INGREDIENT | 1GEV3BAW9J | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| LABETALOL | ACTIVE MOIETY | R5H8897N95 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68258-6047 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | Legacy NDC, 2 package rows | 20131107_167c5861-c51b-45b2-9973-8e02e6ffc041.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68258-6047-3 | 68258604703 | 30 in 1 BOTTLE | Historical |
| 68258-6047-9 | 68258604709 | 90 in 1 PACKAGE | Historical |