Propranolol Hydrochloride
- Product NDC
- 0054-3730
- 11-digit product format
- 000543730
- Labeler code
- 0054
- Product ID
- 0054-3730_245a43cc-cbf8-486d-ad3c-724aca63fd72
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Propranolol Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA070690
- Marketing category
- ANDA
- Marketing start
- 1987-05-15
- Substance
- PROPRANOLOL HYDROCHLORIDE
- Active strength
- 40 mg/5mL
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Propranolol Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROPRANOLOL HYDROCHLORIDE | 40 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F8A3652H1V |
| Rxcui | 856724, 856733 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-3730-63 | Propranolol Hydrochloride | 500 mL in 1 BOTTLE, PLASTIC | SOLUTION | 500 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PROPRANOLOL HYDROCHLORIDE | ACTIVE INGREDIENT | F8A3652H1V | PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 6 | |
| PROPRANOLOL | ACTIVE MOIETY | 9Y8NXQ24VQ | PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 6 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 6 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 6 | |
| EDETATE CALCIUM DISODIUM | INACTIVE INGREDIENT | 25IH6R4SGF | PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 6 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 6 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 6 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 6 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 6 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 6 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-3730 | PROPRANOLOL HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 11 | Current NDC, Legacy NDC, 1 package rows | 20241206_8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-3730-63 | 00054373063 | 500 mL in 1 BOTTLE, PLASTIC (0054-3730-63) | 500 ml | 1987-05-15 | 0000-00-00 | No | No | Current |