Prescription drug · ANDA
Nizatidine NDC 42806-299
Nizatidine 150 mg/1 · Capsule · Oral · Epic Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-299-30 | 42806029930 | 30 CAPSULE in 1 BOTTLE (42806-299-30)Marketed from Oct 25, 2024 | |
| 42806-299-60 | 42806029960 | 60 CAPSULE in 1 BOTTLE (42806-299-60)Marketed from Oct 25, 2024 |
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)
- Nizatidine
- Generic name (nonproprietary)
- nizatidine
- Active ingredients
- Nizatidine — 150 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Epic Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076178
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 42806-299_e9957997-8b85-48a0-9bb3-b878cb223236SPL ID e9957997-8b85-48a0-9bb3-b878cb223236SPL set ID e9957997-8b85-48a0-9bb3-b878cb223236RxCUI 198041, 312025UNII P41PML4GHRUPC 0342806299609, 0342806300305
- 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
N442806029930followed by a unit qualifier and the quantityPackage 42806-0299-30. 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 Nizatidine capsules are indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. Nizatidine capsules are indicated for maintenance therapy for duodenal ulcer patients at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. The consequences of continuous therapy with nizatidine for longer than 1 year are not known. Nizatidine capsules are indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD. Nizatidine capsules are indicated for up to 8 weeks for the treatment of ac…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076178
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 |
|---|---|---|---|---|
| Nizatidine | Nizatidine 300 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-300 |