Ranitidine NDC 53746-253

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-253Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0253Add 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
53746-253-01	53746025301	100 TABLET in 1 BOTTLE (53746-253-01)Marketed from Dec 16, 2009
53746-253-05	53746025305	500 TABLET in 1 BOTTLE (53746-253-05)Marketed from Dec 16, 2009
53746-253-10	53746025310	1000 TABLET in 1 BOTTLE (53746-253-10)Marketed from Dec 16, 2009
53746-253-18	53746025318	180 TABLET in 1 BOTTLE (53746-253-18)Marketed from Dec 16, 2009
53746-253-60	53746025360	60 TABLET in 1 BOTTLE (53746-253-60)Marketed from Dec 16, 2009

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): Ranitidine
Generic name (nonproprietary): ranitidine
Active ingredients: Ranitidine hydrochloride — 150 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077824
Marketing start: Dec 16, 2009
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 53746-253_906b462d-e4a3-4f23-8d1b-2605476c40e8SPL ID 906b462d-e4a3-4f23-8d1b-2605476c40e8SPL set ID b38a3332-5c54-453f-aeb7-070f830955c2RxCUI 198191, 198193UNII BK76465IHMUPC 0353746253019, 0353746254016
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

N453746025301 followed by a unit qualifier and the quantity

Package 53746-0253-01. 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 May 1, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Ranitidine Tablets, USP are indicated in: Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulnes…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077824

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

FDA NDC Directory listings under ANDA 077824
Product	Strength	Form · route	Labeler	Product NDC
Ranitidine	Ranitidine hydrochloride 300 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-254