Over-the-counter drug · ANDA

Acid Reducer (Omeprazole magnesium) NDC 70000-0232

Omeprazole magnesium 20 mg/1 · Capsule, Delayed release · Oral · LEADER/ Cardinal Health 110, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0232Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0232Add 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
70000-0232-170000023201700000232011 BOTTLE in 1 CARTON (70000-0232-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 7, 2017
70000-0232-370000023203700000232033 BOTTLE in 1 CARTON (70000-0232-3) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 7, 2017

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)
Acid Reducer
Generic name (nonproprietary)
omeprazole magnesium
Active ingredients
Omeprazole magnesium — 20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
LEADER/ Cardinal Health 110, Inc.NDC labeler code 70000
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 70000-0232_7dcc8f17-f79a-325e-bb4f-181efdfc0457SPL ID 7dcc8f17-f79a-325e-bb4f-181efdfc0457SPL set ID 1dc00f13-d1f5-15a0-32cc-4fc041865e72RxCUI 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

N470000023201 followed by a unit qualifier and the quantity

Package 70000-0232-01. 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 70000-0232

What is NDC 70000-0232?
70000-0232 is the product NDC for Acid Reducer (omeprazole magnesium), Omeprazole magnesium 20 mg/1 capsule, delayed release, listed with the FDA by LEADER/ Cardinal Health 110, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Acid Reducer (Omeprazole Magnesium).
What is the active ingredient?
Omeprazole magnesium.
Who is the labeler?
LEADER/ Cardinal Health 110, Inc., NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acid Reducer?
33 other product NDCs are listed under this name. See all Acid Reducer 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 Acid Reducer NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Acid ReducerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-62972288-0629-78
Acid ReducerfamotidineFamotidine 10 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-75672288-0756-75
Acid ReducerfamotidineFamotidine 10 mg/1Tablet, Film coatedOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-81651316-0816-3951316-0816-75
Acid ReducercimetidineCimetidine 200 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-47072288-0470-76
Acid ReducerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-51151316-0511-6351316-0511-7151316-0511-78+1 more
Acid ReducerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralPublix Super Markets Inc56062-08856062-0088-02
Acid ReducerfamotidineFamotidine 20 mg/1Tablet, Film coatedOralHyVee Inc42507-19442507-0194-0142507-0194-7142507-0194-78
Acid ReducerfamotidineFamotidine 20 mg/1TabletOralAllegiant Health69168-44569168-0445-3269168-0445-52
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralFamily Dollar Stores, LLC55319-03755319-0037-0555319-0037-62
Acid ReducerfamotidineFamotidine 20 mg/1TabletOralAllegiant Health69168-44369168-0443-0969168-0443-3269168-0443-50+2 more

All 34 Acid Reducer NDCs

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 mg/1Capsule, Delayed releaseOralWalgreens Company0363-0042
Omeprazole MagnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralAlbertsons Companies21130-398
Omeprazole Magnesiumomeprazole magnesium 20.6mg capsulesOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralThe Kroger Co.30142-012
Omeprazole MagnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralHEB37808-006
Omeprazole MagnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralDr. Reddy's Laboratories Inc.43598-813
Omeprazole Magnesiumomeprazole magnesium 20.6mg capsulesOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralWal-Mart Stores Inc49035-397
Omeprazole MagnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralDiscount Drug Mart, Inc53943-520
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 releaseOralCVS Health Corp.69842-027
Omeprazole MagnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralChain Drug Marketing Association83324-117

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