Prescription drug · NDA
Hemangeol (Propranolol hydrochloride) NDC 64370-375
Propranolol hydrochloride 4.28 mg/mL · Solution · Oral · Pierre Fabre Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64370-375-01 | 6437003750164370037501 | 1 BOTTLE, GLASS in 1 CARTON (64370-375-01) / 120 mL in 1 BOTTLE, GLASSMarketed from Apr 14, 2014 | |
| 64370-375-50 | 6437003755064370037550 | 1 BOTTLE, GLASS in 1 CARTON (64370-375-50) / 50 mL in 1 BOTTLE, GLASSMarketed from Apr 14, 2014 |
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)
- Hemangeol
- Generic name (nonproprietary)
- propranolol hydrochloride
- Active ingredients
- Propranolol hydrochloride — 4.28 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Pierre Fabre Pharmaceuticals, Inc.NDC labeler code 64370
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205410
- Marketing start
- Marketing end
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 64370-375_551a9e2a-5afe-b9b8-e063-6394a90a4b63SPL ID 551a9e2a-5afe-b9b8-e063-6394a90a4b63SPL set ID b6f9dd2a-632b-87eb-70f0-b2064d7ed48aRxCUI 1495058, 1495064UNII F8A3652H1VUPC 0364370375015
- 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
N464370037501followed by a unit qualifier and the quantityPackage 64370-0375-01. 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 .
Indications (excerpt from the label)
HEMANGEOL oral solution contains the beta-adrenergic blocker propranolol hydrochloride and is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy. HEMANGEOL oral solution is a beta-adrenergic blocker indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 64370-375
- What is NDC 64370-375?
- 64370-375 is the product NDC for Hemangeol (propranolol hydrochloride), Propranolol hydrochloride 4.28 mg/mL solution, listed with the FDA by Pierre Fabre Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hemangeol (Propranolol hydrochloride).
- What is the active ingredient?
- Propranolol hydrochloride.
- Who is the labeler?
- Pierre Fabre Pharmaceuticals, Inc., NDC labeler code 64370. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hemangeol?
- 1 other product NDC are listed under this name. See all Hemangeol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hemangeol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hemangeolpropranolol hydrochloride | Propranolol hydrochloride 4.28 mg/mL | SolutionOral | Eton Pharmaceuticals, Inc. | 71863-132 | 71863-0132-1271863-0132-5071863-0132-51 |
Other NDCs under NDA 205410
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 |
|---|---|---|---|---|
| Hemangeolpropranolol hydrochloride | Propranolol hydrochloride 4.28 mg/mL | SolutionOral | Eton Pharmaceuticals, Inc. | 71863-132 |