Nizatidine NDC 55111-310

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-310Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0310Add 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
55111-310-01	55111031001	100 CAPSULE in 1 BOTTLE (55111-310-01)Marketed from Sep 15, 2005
55111-310-05	55111031005	500 CAPSULE in 1 BOTTLE (55111-310-05)Marketed from Sep 15, 2005
55111-310-30	55111031030	30 CAPSULE in 1 BOTTLE (55111-310-30)Marketed from Sep 15, 2005
55111-310-60	55111031060	60 CAPSULE in 1 BOTTLE (55111-310-60)Marketed from Sep 15, 2005
55111-310-78	55111031078	10 BLISTER PACK in 1 CARTON (55111-310-78) / 10 CAPSULE in 1 BLISTER PACK (55111-310-79)Marketed from Sep 15, 2005

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: Dr Reddy's Laboratories Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077314
Marketing start: Sep 15, 2005
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 55111-310_254e5866-1ba8-8d97-bc03-19916119ff87SPL ID 254e5866-1ba8-8d97-bc03-19916119ff87SPL set ID faaa7cc4-fda9-d5b8-de2a-71c8744ccb76RxCUI 198041, 312025UNII 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

N455111031001 followed by a unit qualifier and the quantity

Package 55111-0310-01. 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 Dec 6, 2018.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077314

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 077314
Product	Strength	Form · route	Labeler	Product NDC
Nizatidine	Nizatidine 300 mg/1	CapsuleOral	Dr Reddy's Laboratories Limited	55111-311