NDC codes

FDA NDC Directory
Product NDC (as listed)37835-001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width37835-0001Add 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
37835-001-1437835000114378350001141 BOTTLE in 1 CARTON (37835-001-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 30, 2019
37835-001-4237835000142378350001423 BOTTLE in 1 CARTON (37835-001-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 30, 2019

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
Generic name (nonproprietary)
omeprazole
Active ingredients
Omeprazole — 20 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Labeler
BI-MARTNDC labeler code 37835
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207891
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 37835-001_31dbc48a-ec90-e368-e063-6294a90a6c96SPL ID 31dbc48a-ec90-e368-e063-6294a90a6c96SPL set ID fb089d15-daa4-477a-be83-ecd55c3283d4RxCUI 402014UNII 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

N437835000114 followed by a unit qualifier and the quantity

Package 37835-0001-14. 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)

About NDC 37835-001

What is NDC 37835-001?
37835-001 is the product NDC for Omeprazole, Omeprazole 20 mg/1 tablet, delayed release, listed with the FDA by BI-MART. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Omeprazole.
What is the active ingredient?
Omeprazole.
Who is the labeler?
BI-MART, NDC labeler code 37835. 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?
252 other product NDCs are listed under this name. See all Omeprazole NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Omeprazole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
OmeprazoleOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralChain Drug Marketing Association, Inc.83324-30983324-0309-1483324-0309-42
OmeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralAmazon.com Services LLC72288-66672288-0666-5572288-0666-74
Omeprazoleomeprazole magnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralYYBA CORP73581-01573581-0015-03
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralDiscount Drug Mart, Inc53943-03853943-0038-1453943-0038-42
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralAmazon.com Services LLC72288-93472288-0934-01
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralH E B59640-69959640-0699-0159640-0699-03
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralUnit Dose Solutions, Inc.87441-06387441-0063-01
OmeprazoleOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralSafeway21130-78321130-0783-0121130-0783-03
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralPreferred Phharmaceuticals Inc.68788-410468788-4104-0168788-4104-0268788-4104-03+4 more
omeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-60672288-0606-03

All 253 Omeprazole NDCs

Other NDCs under ANDA 207891

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

FDA NDC Directory listings under ANDA 207891
ProductStrengthForm · routeLabelerProduct NDC
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralSun Pharmaceutical Industries, Inc.62756-377
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralLiving Better Brands LLC21130-991
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralTwin Med LLC55681-306
omeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralLittle Pharma, Inc.72559-014
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralHARRIS TEETER72036-981
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralVALU MERCHANDISERS COMPANY63941-997
omeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralTHE KROGER COMPANY30142-992
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralStrategic Sourcing Services70677-0148
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralGERI-CARE PHARMACEUTICALS, CORP57896-659
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralOHM LABORATORIES INC.51660-029
omeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralINNOVUS PHARMACEUTICALS, INC.57483-840
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralRedpharm Drug67296-2183
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralDiscount Drug Mart, Inc53943-038
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralSTRATEGIC SOURCING SERVICES LLC70677-1098

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