Labetalol HCL
- Product NDC
- 49884-122
- 11-digit product format
- 498840122
- Labeler code
- 49884
- Product ID
- 49884-122_c2fd5bf2-ce6b-48a7-a782-17dd1df2d326
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA200908
- Marketing category
- ANDA
- Marketing start
- 2012-07-24
- Marketing end
- 0000-00-00
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LABETALOL HYDROCHLORIDE | ACTIVE INGREDIENT | 1GEV3BAW9J | LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 9 | |
| LABETALOL | ACTIVE MOIETY | R5H8897N95 | LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 9 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 9 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 9 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 9 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 9 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 9 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 9 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-122 | LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [ENDO USA, INC.] | 16 | Legacy NDC | 20240926_56ab2ff4-14a6-4297-afd8-56b92e1f64a0.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 |
|---|
| 49884-122-01 | 49884012201 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49884-122-01) | 2012-07-24 | 0000-00-00 | No | No | Current |
| 49884-122-05 | 49884012205 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49884-122-05) | 2012-07-24 | 0000-00-00 | No | No | Current |