Prescription drug · ANDA
Propranolol Hydrochloride NDC 0121-0908
Propranolol hydrochloride 20 mg/5mL · Solution · Oral · Pharmaceutical Associates, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-0908-40 | 00121090840 | 4 TRAY in 1 CASE (0121-0908-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0908-05)Marketed from Sep 3, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Propranolol Hydrochloride
- Generic name (nonproprietary)
- propranolol hydrochloride
- Active ingredients
- Propranolol hydrochloride — 20 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070979
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 0121-0908_e20b8c76-152c-9fee-e053-2a95a90aa52dSPL ID e20b8c76-152c-9fee-e053-2a95a90aa52dSPL set ID ec5c919b-05d1-45d2-a6e4-ac4ae1101dbbRxCUI 856724UNII F8A3652H1V
- Pharmacologic class
- beta-Adrenergic Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400121090840followed by a unit qualifier and the quantityPackage 00121-0908-40. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Hypertension Propranolol hydrochloride is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation Propranolol hydrochloride is indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction Propranolol hydrochloride is indicated …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070979
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Propranolol Hydrochloride | Propranolol hydrochloride 20 mg/5mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-3728 |
| Propranolol Hydrochloride | Propranolol hydrochloride 20 mg/5mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-8728 |