Omeprazole and Sodium Bicarbonate NDC 85509-1031

NDC codes

FDA NDC Directory

Product NDC (as listed)85509-1031Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85509-1031Add 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
85509-1031-1	85509103101	15 CAPSULE in 1 BOTTLE (85509-1031-1)Marketed from Jul 30, 2025
85509-1031-3	85509103103	30 CAPSULE in 1 BOTTLE (85509-1031-3)Marketed from Jul 30, 2025
85509-1031-6	85509103106	60 CAPSULE in 1 BOTTLE (85509-1031-6)Marketed from Jul 30, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Omeprazole and Sodium Bicarbonate
Generic name (nonproprietary): omeprazole and sodium bicarbonate
Active ingredients: Omeprazole — 20 mg/1Sodium bicarbonate — 1100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: PHOENIX RX LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204228
Marketing start: Jul 15, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Alkalinizing Activity (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 85509-1031_3b2bf542-9d8a-6ff6-e063-6394a90a3faeSPL ID 3b2bf542-9d8a-6ff6-e063-6394a90a3faeSPL set ID 3b2bf501-fd81-6ffa-e063-6394a90afe42RxCUI 616539UNII KG60484QX9, 8MDF5V39QO
Pharmacologic class: Proton Pump Inhibitor

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

N485509103101 followed by a unit qualifier and the quantity

Package 85509-1031-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 204228

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

FDA NDC Directory listings under ANDA 204228
Product	Strength	Form · route	Labeler	Product NDC
Omeprazole and Sodium Bicarbonate	Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1	CapsuleOral	PHOENIX RX LLC	85509-1032
Omeprazole/Sodiium Bicarbonate	Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1	CapsuleOral	Direct_rx	72189-568
Omeprazole and Sodium Bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1	CapsuleOral	Ajanta Pharma USA Inc.	27241-031
Omeprazole and Sodium Bicarbonate	Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1	CapsuleOral	Ajanta Pharma USA Inc.	27241-032