NDC 61919-488

Propranolol hcl ER

Propranolol Hcl Er

Propranolol hcl ER is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Propranolol Hydrochloride.

• Product ID: 61919-488_5c370417-eff1-7280-e053-2a91aa0a1446
• NDC: 61919-488
• Product Type: Human Prescription Drug
• Proprietary Name: Propranolol hcl ER
• Generic Name: Propranolol Hcl Er
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2017-10-23
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA018553
• Labeler Name: Direct Rx
• Substance Name: PROPRANOLOL HYDROCHLORIDE
• Active Ingredient Strength: 60 mg/1
• Pharm Classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 61919-488-30

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (61919-488-30)

• Marketing Start Date: 2017-10-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-488-30 [61919048830]

Propranolol hcl ER CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA authorized generic
• Application Number: NDA018553
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-10-23

Drug Details

Active Ingredients

Ingredient	Strength
PROPRANOLOL HYDROCHLORIDE	60 mg/1

OpenFDA Data

• SPL SET ID: 5c370417-eff0-7280-e053-2a91aa0a1446
• Manufacturer:
  • Direct Rx
• UNII:
  • F8A3652H1V
• RxNorm Concept Unique ID - RxCUI:
  • 856535
  • 856569

Pharmacological Class

• Adrenergic beta-Antagonists [MoA]
• beta-Adrenergic Blocker [EPC]

NDC Crossover Matching brand name "Propranolol hcl ER" or generic name "Propranolol Hcl Er"

NDC	Brand Name	Generic Name
61919-488	Propranolol hcl ER	Propranolol hcl ER
61919-794	Propranolol HCL ER	Propranolol HCL ER