Prescription drug · ANDA
Famotidine NDC 42571-433
Famotidine 40 mg/5mL · Powder, For suspension · Oral · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-433-45 | 42571043345 | 50 mL in 1 BOTTLE (42571-433-45)Marketed from Dec 1, 2023 |
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)
- Famotidine
- Generic name (nonproprietary)
- famotidine
- Active ingredients
- Famotidine — 40 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Micro Labs Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217842
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 42571-433_3b0aa4df-ee1f-e4e3-e063-6394a90a4c66SPL ID 3b0aa4df-ee1f-e4e3-e063-6394a90a4c66SPL set ID 1756ab7d-05c4-4726-8f72-4e8363440968RxCUI 310274UNII 5QZO15J2Z8UPC 0342571433451
- Pharmacologic class
- Histamine-2 Receptor Antagonist
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
N442571043345followed by a unit qualifier and the quantityPackage 42571-0433-45. 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)
Famotidine for oral suspension is indicated in adults for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of DU recurrence. Famotidine for oral suspension is indicated in pediatric patients 1 year of age and older for the treatment of: peptic ulcer disease. GERD with or without esophagitis and ulcerations. Famotidine for oral suspension is indicated in pediatric patients from birth to less than 1 year of age for t…
Excerpt only. Read the full label for complete information.
- openFDA data updated
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