Propranolol Hydrochloride
- Product NDC
- 0591-5557
- 11-digit product format
- 005915557
- Labeler code
- 0591
- Product ID
- 0591-5557_c9eb1f85-2694-465e-9bca-17793419256c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Propranolol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA070178
- Marketing category
- ANDA
- Marketing start
- 1986-05-13
- Marketing end
- 0000-00-00
- Substance
- PROPRANOLOL HYDROCHLORIDE
- Active strength
- 80 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
Additional Listing Data#
- Finished product
- No
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROPRANOLOL HYDROCHLORIDE | 80 mg/1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PROPRANOLOL HYDROCHLORIDE | ACTIVE INGREDIENT | F8A3652H1V | PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] | 7 | |
| PROPRANOLOL | ACTIVE MOIETY | 9Y8NXQ24VQ | PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] | 7 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] | 7 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] | 7 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] | 7 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] | 7 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] | 7 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-5557 | PROPRANOLOL HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] | 14 | Legacy NDC | 20240517_ab9e5678-db53-4354-998a-ed8bf1d33e90.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-5557-01 | 00591555701 | 100 TABLET in 1 BOTTLE, PLASTIC (0591-5557-01) | 100 tablet | 1986-05-13 | 0000-00-00 | No | No | Current |
| 0591-5557-05 | 00591555705 | 500 TABLET in 1 BOTTLE, PLASTIC (0591-5557-05) | 500 tablet | 1986-05-13 | 0000-00-00 | No | No | Current |