Pylera NDC 61269-381

NDC codes

FDA NDC Directory

Product NDC (as listed)61269-381Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61269-0381Add 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
61269-381-12	61269038112	10 BLISTER PACK in 1 BOX (61269-381-12) / 12 CAPSULE in 1 BLISTER PACKMarketed from Aug 18, 2025

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): Pylera
Generic name (nonproprietary): bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride
Active ingredients: Bismuth subcitrate potassium — 140 mg/1Metronidazole — 125 mg/1Tetracycline hydrochloride — 125 mg/1
Dosage form: Capsule
Route: Oral
Labeler: H2-Pharma, LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 050786
Marketing start: Aug 18, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Bismuth (Chemical structure)Nitroimidazoles (Chemical structure)Tetracyclines (Chemical structure)
Identifiers: Product ID 61269-381_b0853a86-d7e4-400b-b21b-5379fbabfe0fSPL ID b0853a86-d7e4-400b-b21b-5379fbabfe0fSPL set ID c50626a2-5969-490b-a88a-a4ee45e79615RxCUI 1294619, 1294621UNII R3O80H60KX, 140QMO216E, P6R62377KV
Pharmacologic class: Bismuth; Nitroimidazole Antimicrobial; Tetracycline-class Antimicrobial

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

N461269038112 followed by a unit qualifier and the quantity

Package 61269-0381-12. 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 16, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

PYLERA is a combination of metronidazole, a nitroimidazole antimicrobial, tetracycline,- a tetracycline class antimicrobial and bismuth subcitrate potassium, indicated for use, in combination with omeprazole, for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of PYLERA and other antibacterial drugs, PYLERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.2 ) 1.1 Eradication of Helicobacter pylori in Patients with Active Du…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 050786

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

FDA NDC Directory listings under NDA 050786
Product	Strength	Form · route	Labeler	Product NDC
Pylerabismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride	Bismuth subcitrate potassium 140 mg/1 + 2 more ingredients	CapsuleOral	H2-Pharma, LLC	61269-380
Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride	Bismuth subcitrate potassium 140 mg/1 + 2 more ingredients	CapsuleOral	H2-Pharma, LLC	61269-386