Prescription drug · ANDA
propranolol hydrochloride NDC 53401-042
Propranolol hydrochloride 60 mg/1 · Capsule, Extended release · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)53401-042Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53401-0042Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53401-042-53 | 5340100425353401004253 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53401-042-53)Marketed from Oct 12, 2026 | |
| 53401-042-60 | 5340100426053401004260 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53401-042-60)Marketed from Oct 12, 2026 | |
| 53401-042-80 | 5340100428053401004280 | 180 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53401-042-80)Marketed from Oct 12, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 60 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 53401
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078703
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 53401-042_5dbeae96-4835-ca9e-e063-6394a90a89c6SPL ID 5dbeae96-4835-ca9e-e063-6394a90a89c6
- 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
N453401004253followed by a unit qualifier and the quantityPackage 53401-0042-53. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 53401-042
- What is NDC 53401-042?
- 53401-042 is the product NDC for propranolol hydrochloride, Propranolol hydrochloride 60 mg/1 capsule, extended release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- propranolol hydrochloride.
- What is the active ingredient?
- Propranolol hydrochloride.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 53401. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for propranolol hydrochloride?
- 196 other product NDCs are listed under this name. See all propranolol hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other propranolol 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) |
|---|---|---|---|---|---|
| Propranolol Hydrochloride | Propranolol hydrochloride 40 mg/1 | TabletOral | American Health Packaging | 60687-948 | 60687-0948-01 |
| Propranolol Hydrochloride | Propranolol hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Creekwood Pharmaceuticals LLC | 82619-132 | 82619-0132-0182619-0132-02 |
| Propranolol Hydrochloride | Propranolol hydrochloride 80 mg/1 | Capsule, Extended releaseOral | Creekwood Pharmaceuticals LLC | 82619-133 | 82619-0133-0182619-0133-02 |
| Propranolol Hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Creekwood Pharmaceuticals LLC | 82619-134 | 82619-0134-0182619-0134-02 |
| Propranolol Hydrochloride | Propranolol hydrochloride 160 mg/1 | Capsule, Extended releaseOral | Creekwood Pharmaceuticals LLC | 82619-135 | 82619-0135-0182619-0135-02 |
| Propranolol Hydrochloride | Propranolol hydrochloride 20 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0958 | 00121-0958-16 |
| Propranolol Hydrochloride | Propranolol hydrochloride 20 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-4958 | 00121-4958-40 |
| Propranolol Hydrochloride | Propranolol hydrochloride 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2584 | 55154-2584-00 |
| Propranolol Hydrochloride | Propranolol hydrochloride 20 mg/1 | TabletOral | American Health Packaging | 60687-937 | 60687-0937-01 |
| Propranolol Hydrochloride | Propranolol hydrochloride 10 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0583 | 80425-0583-0180425-0583-0280425-0583-03 |
Other NDCs under ANDA 078703
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 60 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-522 |
| propranolol hydrochloride | Propranolol hydrochloride 80 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-523 |
| propranolol hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-524 |
| propranolol hydrochloride | Propranolol hydrochloride 160 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-525 |
| propranolol hydrochloride | Propranolol hydrochloride 80 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-1501 |
| propranolol hydrochloride | Propranolol hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Breckenridge Pharmaceutical, Inc. | 51991-817 |
| propranolol hydrochloride | Propranolol hydrochloride 80 mg/1 | Capsule, Extended releaseOral | Breckenridge Pharmaceutical, Inc. | 51991-818 |
| propranolol hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Breckenridge Pharmaceutical, Inc. | 51991-819 |
| propranolol hydrochloride | Propranolol hydrochloride 160 mg/1 | Capsule, Extended releaseOral | Breckenridge Pharmaceutical, Inc. | 51991-820 |
| Propranolol Hydrochloride | Propranolol hydrochloride 60 mg/1 | Capsule, Extended releaseOral | American Health Packaging | 60687-215 |
| Propranolol Hydrochloride | Propranolol hydrochloride 80 mg/1 | Capsule, Extended releaseOral | American Health Packaging | 60687-226 |
| propranolol hydrochloride | Propranolol hydrochloride 80 mg/1 | Capsule, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-589 |
| propranolol hydrochloride | Propranolol hydrochloride 60 mg/1 | Capsule, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-867 |
| propranolol hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-2069 |
| propranolol hydrochloride | Propranolol hydrochloride 160 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-2070 |
| propranolol hydrochloride | Propranolol hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-2071 |
| propranolol hydrochloride | Propranolol hydrochloride 80 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-2072 |
| propranolol hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-9282 |
| propranolol hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-1463 |
| propranolol hydrochloride | Propranolol hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-0234 |
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