What is NDC 72189-568?

72189-568 is the product NDC for Omeprazole/Sodiium Bicarbonate, Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1 capsule, listed with the FDA by Direct_rx. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Omeprazole, Sodium bicarbonate.

Direct_rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Omeprazole/Sodiium Bicarbonate?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Omeprazole/Sodiium Bicarbonate NDC 72189-568

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-568Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0568Add 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
72189-568-30	7218905683072189056830	30 CAPSULE in 1 BOTTLE (72189-568-30)Marketed from Aug 12, 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): Omeprazole/Sodiium Bicarbonate
Generic name (nonproprietary): omeprazole/sodiium bicarbonate
Active ingredients: Omeprazole — 40 mg/1Sodium bicarbonate — 1100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Direct_rxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204228
Marketing start: Aug 12, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Alkalinizing Activity (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 72189-568_1f7f63c1-17c3-9a05-e063-6394a90abc6fSPL ID 1f7f63c1-17c3-9a05-e063-6394a90abc6fSPL set ID 1f7f63c1-17c2-9a05-e063-6394a90abc6fRxCUI 616541UNII 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

N472189056830 followed by a unit qualifier and the quantity

Package 72189-0568-30. 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 12, 2024.

Indications (excerpt from the label)

Omeprazole and Sodium Bicarbonate capsules are indicated in adults for the: short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. short-term treatment (4 to 8 weeks) of active benign gastric ulcer. treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults. The efficacy of Omeprazole and Sodium Bicarbonate capsules used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 week…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-568

What is NDC 72189-568?: 72189-568 is the product NDC for Omeprazole/Sodiium Bicarbonate, Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1 capsule, listed with the FDA by Direct_rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Omeprazole/Sodiium Bicarbonate.
What is the active ingredient?: Omeprazole, Sodium bicarbonate.
Who is the labeler?: Direct_rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Omeprazole/Sodiium Bicarbonate?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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 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
Omeprazole and Sodium Bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1	CapsuleOral	PHOENIX RX LLC	85509-1031
Omeprazole and Sodium Bicarbonate	Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1	CapsuleOral	PHOENIX RX LLC	85509-1032