Cimetidine NDC 62135-631

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-631Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0631Add 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
62135-631-90	62135063190	90 TABLET, FILM COATED in 1 BOTTLE (62135-631-90)Marketed from Aug 15, 2023

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): Cimetidine
Generic name (nonproprietary): cimetidine
Active ingredients: Cimetidine — 300 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Chartwell RX, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074329
Marketing start: May 17, 1994
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 62135-631_0337689b-c5d5-d881-e063-6394a90aaec9SPL ID 0337689b-c5d5-d881-e063-6394a90aaec9SPL set ID 01997826-7ca1-473e-bfc9-075b14b58a35RxCUI 197505, 197506, 197507, 197508UNII 80061L1WGDUPC 0362135633905, 0362135630300, 0362135631901, 0362135632908
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

N462135063190 followed by a unit qualifier and the quantity

Package 62135-0631-90. 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 Aug 18, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Cimetidine tablets are indicated in: 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION: Duodenal Ulcer ). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of cimetidine tablets and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 074329

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

FDA NDC Directory listings under ANDA 074329
Product	Strength	Form · route	Labeler	Product NDC
Cimetidine	Cimetidine 800 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-633
Cimetidine	Cimetidine 200 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-630
Cimetidine	Cimetidine 400 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-632