Prescription drug · ANDA
Propafenone Hydrochloride NDC 63629-2105
Propafenone hydrochloride 150 mg/1 · Tablet, Coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2105-1 | 6362921050163629210501 | 100 TABLET, COATED in 1 BOTTLE (63629-2105-1)Marketed from Jan 29, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Propafenone Hydrochloride
- Generic name (nonproprietary)
- propafenone hydrochloride
- Active ingredients
- Propafenone hydrochloride — 150 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076550
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-2105_ae1bf45c-2106-497f-a42a-8fcc4ce3d9adSPL ID ae1bf45c-2106-497f-a42a-8fcc4ce3d9adSPL set ID 9da7e6d2-64da-43cd-9575-b2b0d5d412dcRxCUI 861424UNII 33XCH0HOCD
- Pharmacologic class
- Antiarrhythmic
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
N463629210501followed by a unit qualifier and the quantityPackage 63629-2105-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Propafenone Hydrochloride Tablets are indicated to: • prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease. • prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease. • treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital. Usage Considerations: • The use of Propafenone Hydrochloride Tablets in patients with permanent atrial fibrillation (AF) or in patients ex…
Excerpt only. Read the full label for complete information.
About NDC 63629-2105
- What is NDC 63629-2105?
- 63629-2105 is the product NDC for Propafenone Hydrochloride, Propafenone hydrochloride 150 mg/1 tablet, coated, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Propafenone Hydrochloride.
- What is the active ingredient?
- Propafenone hydrochloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Propafenone Hydrochloride?
- 52 other product NDCs are listed under this name. See all Propafenone Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Propafenone Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Propafenone Hydrochloride | Propafenone hydrochloride 150 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-930 | 60687-0930-01 |
| Propafenone Hydrochloride | Propafenone hydrochloride 300 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-246 | 64380-0246-01 |
| Propafenone Hydrochloride | Propafenone hydrochloride 225 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-268 | 64380-0268-0164380-0268-02 |
| Propafenone Hydrochloride | Propafenone hydrochloride 150 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-269 | 64380-0269-0164380-0269-02 |
| Propafenone Hydrochloride | Propafenone hydrochloride 225 mg/1 | Capsule, Extended releaseOral | Aurobindo Pharma Limited | 59651-276 | 59651-0276-0559651-0276-6059651-0276-90 |
| Propafenone Hydrochloride | Propafenone hydrochloride 325 mg/1 | Capsule, Extended releaseOral | Aurobindo Pharma Limited | 59651-277 | 59651-0277-0559651-0277-6059651-0277-90 |
| Propafenone Hydrochloride | Propafenone hydrochloride 425 mg/1 | Capsule, Extended releaseOral | Aurobindo Pharma Limited | 59651-278 | 59651-0278-0559651-0278-6059651-0278-90 |
| Propafenone Hydrochloride | Propafenone hydrochloride 150 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-709 | 60687-0709-01 |
| Propafenone Hydrochloride | Propafenone hydrochloride 300 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-163 | 64380-0163-01 |
| Propafenone Hydrochloride | Propafenone hydrochloride 225 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-164 | 64380-0164-0164380-0164-02 |
Other NDCs under ANDA 076550
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 |
|---|---|---|---|---|
| Propafenone Hydrochloride | Propafenone hydrochloride 225 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-4227 |
| Propafenone Hydrochloride | Propafenone hydrochloride 150 mg/1 | Tablet, CoatedOral | Golden State Medical Supply, Inc. | 51407-015 |
| Propafenone Hydrochloride | Propafenone hydrochloride 225 mg/1 | Tablet, CoatedOral | Golden State Medical Supply, Inc. | 51407-016 |
| Propafenone Hydrochloride | Propafenone hydrochloride 300 mg/1 | Tablet, CoatedOral | Golden State Medical Supply, Inc. | 51407-017 |
| Propafenone Hydrochloride | Propafenone hydrochloride 150 mg/1 | Tablet, CoatedOral | ANI Pharmaceuticals, Inc. | 62559-230 |
| Propafenone Hydrochloride | Propafenone hydrochloride 225 mg/1 | Tablet, CoatedOral | ANI Pharmaceuticals, Inc. | 62559-231 |
| Propafenone Hydrochloride | Propafenone hydrochloride 300 mg/1 | Tablet, CoatedOral | ANI Pharmaceuticals, Inc. | 62559-232 |
| Propafenone Hydrochloride | Propafenone hydrochloride 225 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 63629-1988 |
| Propafenone Hydrochloride | Propafenone hydrochloride 300 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 63629-1989 |
| Propafenone Hydrochloride | Propafenone hydrochloride 300 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 63629-9280 |
| Propafenone Hydrochloride | Propafenone hydrochloride 150 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-2780 |
| Propafenone Hydrochloride | Propafenone hydrochloride 150 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 72162-1751 |
| Propafenone Hydrochloride | Propafenone hydrochloride 225 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 72162-1752 |
| Propafenone Hydrochloride | Propafenone hydrochloride 300 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 72162-1753 |