Labetalol hydrochloride
- Product NDC
- 0591-0605
- 11-digit product format
- 005910605
- Labeler code
- 0591
- Product ID
- 0591-0605_d5dfcb69-d2c4-49ca-a684-83c9e15b3b06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA075133
- Marketing category
- ANDA
- Marketing start
- 1998-08-03
- Marketing end
- 2026-09-30
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Labetalol hydrochloride
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LABETALOL HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1GEV3BAW9J |
| Rxcui | 896758, 896762, 896766 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0591-0605-01 | Labetalol hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 16 |
| 0591-0605-05 | Labetalol hydrochloride | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 16 |
| 0591-0605-10 | Labetalol hydrochloride | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 16 |
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 [WATSON LABORATORIES, INC.] | 9 | |
| LABETALOL | ACTIVE MOIETY | R5H8897N95 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 9 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 9 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 9 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 9 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 9 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 9 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 9 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 9 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 9 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 9 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 9 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 9 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] | 9 | |
| LABETALOL HYDROCHLORIDE | ACTIVE INGREDIENT | 1GEV3BAW9J | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 2 | |
| LABETALOL | ACTIVE MOIETY | R5H8897N95 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-0605 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 15 | Current NDC, Legacy NDC, 3 package rows | 20181129_a5b65a9b-6b8a-48a4-9c72-0e605bb309eb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-0605-01 | 00591060501 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0605-01) | 1998-08-03 | 2026-09-30 | No | No | Current |
| 0591-0605-05 | 00591060505 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0605-05) | 1998-08-03 | 2026-09-30 | No | No | Current |
| 0591-0605-10 | 00591060510 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0605-10) | 1998-08-03 | 0000-00-00 | No | No | Current |