Propranolol Hydrochloride
- Product NDC
- 68788-8620
- 11-digit product format
- 687888620
- Labeler code
- 68788
- Product ID
- 68788-8620_8c765672-66b8-44bb-8252-792d539e057b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Propranolol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA070322
- Marketing category
- ANDA
- Marketing start
- 2024-04-02
- Substance
- PROPRANOLOL HYDROCHLORIDE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 68788-8620_8c765672-66b8-44bb-8252-792d539e057b
- SPL ID
- 8c765672-66b8-44bb-8252-792d539e057b
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Propranolol Hydrochloride
- Generic name
- Propranolol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2024-04-02
- Marketing category
- ANDA
- Application number
- ANDA070322
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA]; beta-Adrenergic Blocker [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| PROPRANOLOL HYDROCHLORIDE | 40 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | F8A3652H1V |
| Rxcui | 856519 |
| Spl Set Id | 52da1afc-7f1c-4893-ab84-8479dd939951 |
| Manufacturer Name | Preferred Pharmaceuticals Inc. |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 68788-8620-1 | 100 TABLET in 1 BOTTLE (68788-8620-1) | 2024-04-02 | No |
| 68788-8620-3 | 30 TABLET in 1 BOTTLE (68788-8620-3) | 2024-04-02 | No |
| 68788-8620-6 | 60 TABLET in 1 BOTTLE (68788-8620-6) | 2024-04-02 | No |
| 68788-8620-9 | 90 TABLET in 1 BOTTLE (68788-8620-9) | 2024-04-02 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| F8A3652H1V | PROPRANOLOL HYDROCHLORIDE | 318-98-9 | PROPRANOLOL HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8620-1 | 68788862001 | 100 TABLET in 1 BOTTLE (68788-8620-1) | 100 tablet | 2024-04-02 | No | No | Historical |
| 68788-8620-3 | 68788862003 | 30 TABLET in 1 BOTTLE (68788-8620-3) | 30 tablet | 2024-04-02 | No | No | Historical |
| 68788-8620-6 | 68788862006 | 60 TABLET in 1 BOTTLE (68788-8620-6) | 60 tablet | 2024-04-02 | No | No | Historical |
| 68788-8620-9 | 68788862009 | 90 TABLET in 1 BOTTLE (68788-8620-9) | 90 tablet | 2024-04-02 | No | No | Historical |