NDC codes

FDA NDC Directory
Product NDC (as listed)27241-031Labeler and product segments. Claims need a package NDC.
Product NDC at billing width27241-0031Add 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 NDC11-digit (billing)PackageCopy
27241-031-032724100310330 CAPSULE in 1 BOTTLE (27241-031-03)Marketed from Jul 15, 2016

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 and Sodium Bicarbonate
Generic name (nonproprietary)
omeprazole and sodium bicarbonate
Active ingredients
Omeprazole20 mg/1Sodium bicarbonate1100 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204228
Marketing start
Listing expires
Other FDA classes
Alkalinizing Activity (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 27241-031_8cfaa15c-6aad-44f8-bd51-468991263affSPL ID 8cfaa15c-6aad-44f8-bd51-468991263affSPL set ID cb657607-b038-47ee-b4e7-a5f419a14c33RxCUI 616539, 616541UNII 8MDF5V39QO, KG60484QX9UPC 0327241031038, 0327241032035
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

N427241003103 followed by a unit qualifier and the quantity

Package 27241-0031-03. 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 .

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 wee

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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
ProductStrengthForm · routeLabelerProduct NDC
Omeprazole and Sodium BicarbonateOmeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1CapsuleOralPHOENIX RX LLC85509-1032
Omeprazole and Sodium BicarbonateOmeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1CapsuleOralPHOENIX RX LLC85509-1031
Omeprazole/Sodiium BicarbonateOmeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1CapsuleOralDirect_rx72189-568
Omeprazole and Sodium BicarbonateOmeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1CapsuleOralAjanta Pharma USA Inc.27241-032

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