Prescription drug · NDA
Inderal XL (Propranolol hydrochloride) NDC 62559-601
Propranolol hydrochloride 120 mg/1 · Capsule, Extended release · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-601-14 | 6255906011462559060114 | 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-14)Marketed from Sep 1, 2021 | |
| 62559-601-30 | 6255906013062559060130 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-30)Marketed from Feb 22, 2018 | |
| 62559-601-77 | 6255906017762559060177 | 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-77)Marketed from Feb 22, 2018 |
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)
- Inderal XL
- Generic name (nonproprietary)
- propranolol hydrochloride
- Active ingredients
- Propranolol hydrochloride — 120 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.NDC labeler code 62559
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021438
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 62559-601_63e1eabb-6c51-4088-bfa7-4a1cdcab4cefSPL ID 63e1eabb-6c51-4088-bfa7-4a1cdcab4cefSPL set ID ac196ff5-9215-402b-bc57-69aa87f8badeRxCUI 856460, 856462, 856569, 856571UNII F8A3652H1VUPC 0362559601306, 0362559600309
- 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
N462559060114followed by a unit qualifier and the quantityPackage 62559-0601-14. 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)
INDERAL XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice…
Excerpt only. Read the full label for complete information.
About NDC 62559-601
- What is NDC 62559-601?
- 62559-601 is the product NDC for Inderal XL (propranolol hydrochloride), Propranolol hydrochloride 120 mg/1 capsule, extended release, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Inderal XL (Propranolol hydrochloride).
- What is the active ingredient?
- Propranolol hydrochloride.
- Who is the labeler?
- ANI Pharmaceuticals, Inc., NDC labeler code 62559. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Inderal XL?
- 1 other product NDC are listed under this name. See all Inderal XL NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Inderal XL products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Inderal XLpropranolol hydrochloride | Propranolol hydrochloride 80 mg/1 | Capsule, Extended releaseOral | ANI Pharmaceuticals, Inc. | 62559-600 | 62559-0600-1462559-0600-3062559-0600-77 |
Other NDCs under NDA 021438
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 |
|---|---|---|---|---|
| Inderal XLpropranolol hydrochloride | Propranolol hydrochloride 80 mg/1 | Capsule, Extended releaseOral | ANI Pharmaceuticals, Inc. | 62559-600 |
| InnoPran XLpropranolol hydrochloride | Propranolol hydrochloride 80 mg/1 | Capsule, Extended releaseOral | ANI Pharmaceuticals, Inc. | 62559-590 |
| InnoPran XLpropranolol hydrochloride | Propranolol hydrochloride 120 mg/1 | Capsule, Extended releaseOral | ANI Pharmaceuticals, Inc. | 62559-591 |