Ranitidine NDC 0121-4727

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-4727Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-4727Add 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
0121-4727-10	00121472710	4 TRAY in 1 CASE (0121-4727-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSEMarketed from Nov 1, 2010

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 15 mg/mL
Dosage form: Syrup
Route: Oral
Labeler: Pharmaceutical Associates, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077405
Marketing start: Nov 1, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0121-4727_d56a22ea-5dab-e98a-e053-2a95a90a34c4SPL ID d56a22ea-5dab-e98a-e053-2a95a90a34c4SPL set ID d0da9dd6-c691-4614-99c7-531b0bf34837RxCUI 705610UNII 884KT10YB7
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

N400121472710 followed by a unit qualifier and the quantity

Package 00121-4727-10. 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 Jan 12, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Ranitidine Syrup (Ranitidine Oral Solution USP) is 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077405

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

FDA NDC Directory listings under ANDA 077405
Product	Strength	Form · route	Labeler	Product NDC
Ranitidine	Ranitidine 15 mg/mL	SyrupOral	Pharmaceutical Associates, Inc.	0121-0727