Prescription drug · ANDA
Humatin (Paromomycin sulfate) NDC 80725-250
Paromomycin sulfate 250 mg/1 · Capsule · Oral · Waylis Therapeutics LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80725-250-01 | 80725025001 | 100 CAPSULE in 1 BOTTLE (80725-250-01)Marketed from Apr 8, 2021 |
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)
- Humatin
- Generic name (nonproprietary)
- paromomycin sulfate
- Active ingredients
- Paromomycin sulfate — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Waylis Therapeutics LLCNDC labeler code 80725
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065173
- Marketing start
- Listing expires
- Identifiers
- Product ID 80725-250_4b33337a-4e4b-42f3-923f-5b61f02fc463SPL ID 4b33337a-4e4b-42f3-923f-5b61f02fc463SPL set ID a725f022-ec3c-430d-8021-96c861b9893cRxCUI 207347, 314184UNII 845NU6GJPSUPC 0380725250011
- Pharmacologic class
- Antiprotozoal
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
N480725025001followed by a unit qualifier and the quantityPackage 80725-0250-01. 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)
INDICATIONS AND USAGE Paromomycin sulfate is indicated for intestinal amebiasis–acute and chronic (NOTE-It is not effective in extraintestinal amebiasis); management of hepatic coma–as adjunctive therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of HUMATIN™ Capsules and other antibacterial drugs, HUMATIN™ Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may …
Excerpt only. Read the full label for complete information.
About NDC 80725-250
- What is NDC 80725-250?
- 80725-250 is the product NDC for Humatin (paromomycin sulfate), Paromomycin sulfate 250 mg/1 capsule, listed with the FDA by Waylis Therapeutics LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Humatin (Paromomycin sulfate).
- What is the active ingredient?
- Paromomycin sulfate.
- Who is the labeler?
- Waylis Therapeutics LLC, NDC labeler code 80725. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Humatin?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.