Omeprazole/Sodium Bicarbonate (omeprazole) NDC 64380-182

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-182Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0182Add 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
64380-182-02	64380018202	30 POUCH in 1 CARTON (64380-182-02) / 20 mg in 1 POUCH (64380-182-01)Marketed from Oct 1, 2022

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/Sodium Bicarbonate
Generic name (nonproprietary): omeprazole
Active ingredients: Omeprazole — 20 mg/1700mgSodium bicarbonate — 1680 mg/1700mg
Dosage form: Powder, For suspension
Route: Oral
Labeler: Strides Pharma Science Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079182
Marketing start: Oct 1, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Alkalinizing Activity (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 64380-182_2ac68a93-2f3b-46aa-a874-c109ad1bfefeSPL ID 2ac68a93-2f3b-46aa-a874-c109ad1bfefeSPL set ID cf6d293e-d70d-443e-8292-d693e93aab55RxCUI 753557, 753562UNII 8MDF5V39QO, KG60484QX9
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

N464380018202 followed by a unit qualifier and the quantity

Package 64380-0182-02. 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 Sep 21, 2023.

Indications (excerpt from the label)

Omeprazole and sodium bicarbonate for oral suspension is 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 for oral suspension 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,…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 079182

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

FDA NDC Directory listings under ANDA 079182
Product	Strength	Form · route	Labeler	Product NDC
Omeprazole/Sodium Bicarbonateomeprazole	Omeprazole 40 mg/1720mg; Sodium bicarbonate 1680 mg/1720mg	Powder, For suspensionOral	Strides Pharma Science Limited	64380-183