What is NDC 0121-1025?

0121-1025 is the product NDC for Cimetidine Hydrochloride, Cimetidine hydrochloride 300 mg/5mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.

PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cimetidine Hydrochloride?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cimetidine Hydrochloride NDC 0121-1025

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-1025Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-1025Add 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
0121-1025-08	0012110250800121102508	237 mL in 1 BOTTLE (0121-1025-08)Marketed from Jan 9, 2025

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): Cimetidine Hydrochloride
Generic name (nonproprietary): cimetidine hydrochloride
Active ingredients: Cimetidine hydrochloride — 300 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074664
Marketing start: Jan 9, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0121-1025_55abdac4-2b7c-4163-bf5f-d2e934108ba6SPL ID 55abdac4-2b7c-4163-bf5f-d2e934108ba6SPL set ID b8b50bd9-bc1b-4da5-96c5-8eb917c8937fRxCUI 212787UNII WF10491673UPC 0301211025081
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

N400121102508 followed by a unit qualifier and the quantity

Package 00121-1025-08. 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 6, 2025.

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)

About NDC 0121-1025

What is NDC 0121-1025?: 0121-1025 is the product NDC for Cimetidine Hydrochloride, Cimetidine hydrochloride 300 mg/5mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cimetidine Hydrochloride.
What is the active ingredient?: Cimetidine hydrochloride.
Who is the labeler?: PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cimetidine Hydrochloride?: 2 other product NDCs are listed under this name. See all Cimetidine Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cimetidine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cimetidine Hydrochloride	Cimetidine hydrochloride 300 mg/5mL	SolutionOral	Chartwell RX, LLC	62135-809	62135-0809-2462135-0809-37
Cimetidine Hydrochloride	Cimetidine hydrochloride 300 mg/5mL	SolutionOral	Chartwell Governmental & Specialty RX, LLC.	68999-809	68999-0809-24