NDC codes

FDA NDC Directory
Product NDC (as listed)55111-397Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55111-0397Add 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
55111-397-27551110397272 BOTTLE in 1 CARTON (55111-397-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 1, 2010
55111-397-28551110397282 CARTON in 1 CARTON (55111-397-28) / 2 BLISTER PACK in 1 CARTON (55111-397-74) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACKMarketed from Mar 1, 2010
55111-397-33551110397333 BOTTLE in 1 CARTON (55111-397-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 1, 2010
55111-397-39551110397393 BOTTLE in 1 CARTON (55111-397-39) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 1, 2015
55111-397-42551110397423 CARTON in 1 CARTON (55111-397-42) / 2 BLISTER PACK in 1 CARTON (55111-397-74) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACKMarketed from Mar 1, 2010
55111-397-52551110397521 BOTTLE in 1 CARTON (55111-397-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 1, 2010

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 Magnesium
Generic name (nonproprietary)
omeprazole magnesium
Active ingredients
Omeprazole magnesium20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078878
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 55111-397_fff9af9d-87b4-7d54-4cc4-c65b07556ec5SPL ID fff9af9d-87b4-7d54-4cc4-c65b07556ec5SPL set ID 0e8fde83-a55c-edaf-3c66-e1fc77d0bc11RxCUI 198051UNII 426QFE7XLK
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

N455111039727 followed by a unit qualifier and the quantity

Package 55111-0397-27. 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)

Use • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078878

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

FDA NDC Directory listings under ANDA 078878
ProductStrengthForm · routeLabelerProduct NDC
Omeprazole Magnesiumomeprazole magnesium 20.6mg capsulesOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralThe Kroger Co.30142-012
Omeprazole MagnesiumOmeprazole magnesium 20.6 mg/1Capsule, Delayed releaseOralGericare Pharmaceuticals57896-759
Omeprazole MagnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralChain Drug Marketing Association63868-177
Omeprazole MagnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralChain Drug Consortium, LLC68016-760
Omeprazole MagnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralHEB37808-006
Omeprazole MagnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralWalgreens Company0363-0042
Omeprazole MagnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralCVS Health Corp.69842-027
Acid Reduceromeprazole magnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralLEADER/ Cardinal Health 110, Inc.70000-0232
Omeprazole MagnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralChain Drug Marketing Association83324-117
Omeprazole Magnesiumomeprazole magnesium 20.6mg capsulesOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralWal-Mart Stores Inc49035-397
Omeprazole MagnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralDr. Reddy's Laboratories Inc.43598-813
Omeprazole MagnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralDiscount Drug Mart, Inc53943-520
Omeprazole MagnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralAlbertsons Companies21130-398

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