Cimetidine Hydrochloride NDC 62135-809

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-809Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0809Add 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
62135-809-24	62135080924	2 TRAY in 1 BOX (62135-809-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-809-05)Marketed from Oct 22, 2024
62135-809-37	62135080937	237 mL in 1 BOTTLE (62135-809-37)Marketed from May 6, 2024

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 Hydrochloride
Generic name (nonproprietary): cimetidine hydrochloride
Active ingredients: Cimetidine hydrochloride — 300 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Chartwell RX, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074251
Marketing start: Dec 22, 1994
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 62135-809_4a162075-ab76-d848-e063-6294a90aaa9bSPL ID 4a162075-ab76-d848-e063-6294a90aaa9bSPL set ID d1d73350-4e7e-428a-90a5-6000fd373a4fRxCUI 212787UNII WF10491673UPC 0362135809379
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

N462135080924 followed by a unit qualifier and the quantity

Package 62135-0809-24. 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 Feb 5, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Cimetidine Hydrochloride Oral Solution is indicated in: (1) Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine 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 oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine. (2) Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment wi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 074251

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

FDA NDC Directory listings under ANDA 074251
Product	Strength	Form · route	Labeler	Product NDC
Cimetidine Hydrochloride	Cimetidine hydrochloride 300 mg/5mL	SolutionOral	Chartwell Governmental & Specialty RX, LLC.	68999-809