Prescription drug · ANDA

Omeprazole NDC 68071-5301

Omeprazole 20 mg/1 · Capsule, Delayed release · Oral · NuCare Pharmaceuticals, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68071-5301Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-5301Add 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
68071-5301-36807153010330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-5301-3)Marketed from Sep 16, 2026
68071-5301-96807153010990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-5301-9)Marketed from Jun 16, 2026

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
Generic name (nonproprietary)
omeprazole
Active ingredients
Omeprazole — 20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078490
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 68071-5301_5b9d859b-cbb2-d5b5-e063-6294a90af89dSPL ID 5b9d859b-cbb2-d5b5-e063-6294a90af89d
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

N468071530103 followed by a unit qualifier and the quantity

Package 68071-5301-03. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under ANDA 078490

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

FDA NDC Directory listings under ANDA 078490
ProductStrengthForm · routeLabelerProduct NDC
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-8771
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-6721
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-6720
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-8805
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralSt. Mary's Medical Park Pharmacy60760-747
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAmerican Health Packaging60687-597
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-0504
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralAmerican Health Packaging60687-608
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralAvPAK50268-657
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralPHOENIX RX LLC85509-1644
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-875
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-876
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralQuallent Pharmaceuticals Health LLC82009-183
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7472
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7473
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7474
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralNorthwind Health Company, LLC82868-080
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals, Inc.68071-3733
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-912
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralNorthStar Rx LLC16714-123

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Omeprazole NDC 68071-5301 | Med-Code