What is NDC 60846-301?

60846-301 is the product NDC for Nizatidine, Nizatidine 15 mg/mL solution, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals LLC, NDC labeler code 60846. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nizatidine?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nizatidine NDC 60846-301 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)60846-301Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60846-0301Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
60846-301-15	6084603011560846030115	480 mL in 1 BOTTLE (60846-301-15)Marketed from Aug 12, 2016

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 — 15 mg/mL
Dosage form: Solution
Route: Oral
Labeler: Amneal Pharmaceuticals LLCNDC labeler code 60846
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090576
Marketing start: Aug 12, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 60846-301_aedc4160-2165-451e-8a3b-26d3bb911242SPL ID aedc4160-2165-451e-8a3b-26d3bb911242SPL set ID 39e62997-8781-449a-e054-00144ff88e88RxCUI 476872UNII P41PML4GHR
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

N460846030115 followed by a unit qualifier and the quantity

Package 60846-0301-15. 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 Oct 23, 2024.

Indications (excerpt from the label)

Indications and Usage: Nizatidine oral solution is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. Nizatidine oral solution is 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 oral solution is 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 oral solution is indicated for up to 8 weeks for th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60846-301

What is NDC 60846-301?: 60846-301 is the product NDC for Nizatidine, Nizatidine 15 mg/mL solution, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nizatidine.
What is the active ingredient?: Nizatidine.
Who is the labeler?: Amneal Pharmaceuticals LLC, NDC labeler code 60846. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nizatidine?: 5 other product NDCs are listed under this name. See all Nizatidine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Nizatidine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nizatidine	Nizatidine 150 mg/1	CapsuleOral	Epic Pharma, LLC	42806-299	42806-0299-3042806-0299-60
Nizatidine	Nizatidine 300 mg/1	CapsuleOral	Epic Pharma, LLC	42806-300	42806-0300-3042806-0300-60
Nizatidine	Nizatidine 150 mg/1	CapsuleOral	Dr Reddy's Laboratories Limited	55111-310	55111-0310-0155111-0310-0555111-0310-30+2 more
Nizatidine	Nizatidine 300 mg/1	CapsuleOral	Dr Reddy's Laboratories Limited	55111-311	55111-0311-0155111-0311-0555111-0311-30+2 more
Nizatidine	Nizatidine 150 mg/1	CapsuleOral	Actavis Pharma, Inc.	0591-3137	00591-3137-60