What is NDC 57237-161?

57237-161 is the product NDC for Omeprazole, Omeprazole 20 mg/1 capsule, delayed release, listed with the FDA by Rising Pharma Holdings, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 57237. 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?

249 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Omeprazole NDC 57237-161 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)57237-161Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57237-0161Add 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 NDC	11-digit (billing)	Package
57237-161-01	57237016101	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-01)Marketed from Aug 19, 2015
57237-161-30	57237016130	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-30)Marketed from Aug 19, 2015
57237-161-50	57237016150	500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-50)Marketed from Aug 19, 2015
57237-161-90	57237016190	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-90)Marketed from Aug 19, 2015
57237-161-99	57237016199	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-99)Marketed from Aug 19, 2015

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: Capsule, Delayed release
Route: Oral
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 57237
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203270
Marketing start: Aug 19, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 57237-161_aec12e35-60fb-416c-a2d0-a87cfdcb30a6SPL ID aec12e35-60fb-416c-a2d0-a87cfdcb30a6SPL set ID a1b1c61b-d4fe-433d-ad31-0b11758976faRxCUI 198051, 199119, 200329UNII KG60484QX9UPC 0357237160305, 0357237161302, 0357237162309
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

N457237016101 followed by a unit qualifier and the quantity

Package 57237-0161-01. 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 Nov 12, 2024.

Indications (excerpt from the label)

Omeprazole is a proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults ( 1.1 ) Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2 ) Treatment of active benign gastric ulcer in adults ( 1.3 ) Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4 ) Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6 ) Pathologic hypersecretory conditions in adults ( 1.7 ) 1.1 Treatment of Active Duodenal Ulcer Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patie…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57237-161

What is NDC 57237-161?: 57237-161 is the product NDC for Omeprazole, Omeprazole 20 mg/1 capsule, delayed release, listed with the FDA by Rising Pharma Holdings, Inc.. It has 5 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?: Rising Pharma Holdings, Inc., NDC labeler code 57237. 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?: 249 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Omeprazole	Omeprazole 20 mg/1	Tablet, Orally disintegrating, Delayed releaseOral	Amazon.com Services LLC	72288-666	72288-0666-55
Omeprazole	Omeprazole 20 mg/1	Tablet, Delayed releaseOral	Discount Drug Mart, Inc	53943-038	53943-0038-1453943-0038-42
Omeprazoleomeprazole magnesium	Omeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	YYBA CORP	73581-015	73581-0015-03
Omeprazole	Omeprazole 20 mg/1	Tablet, Delayed releaseOral	Amazon.com Services LLC	72288-934	72288-0934-01
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	H E B	59640-699	59640-0699-0159640-0699-03
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Unit Dose Solutions, Inc.	87441-063	87441-0063-01
Omeprazole	Omeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	Safeway	21130-783	21130-0783-0121130-0783-03
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Preferred Phharmaceuticals Inc.	68788-4104	68788-4104-0168788-4104-0268788-4104-03+4 more
omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Amazon.com Services LLC	72288-606	72288-0606-03
Omeprazole	Omeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	Walgreen Company	0363-4099	00363-4099-03

All 250 Omeprazole NDCs

Other NDCs under ANDA 203270

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

FDA NDC Directory listings under ANDA 203270
Product	Strength	Form · route	Labeler	Product NDC
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	QPharma, Inc.	42708-159
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	QPharma Inc	42708-199
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	A-S Medication Solutions	50090-7213
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	A-S Medication Solutions	50090-7214
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	A-S Medication Solutions	50090-7215
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	A-S Medication Solutions	50090-7366
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	A-S Medication Solutions	50090-7367
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	Northwind Health Company, LLC	51655-452
Omeprazole	Omeprazole 10 mg/1	Capsule, Delayed releaseOral	Rising Pharma Holdings, Inc.	57237-160
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	Rising Pharma Holdings, Inc.	57237-162
Omeprazole	Omeprazole 10 mg/1	Capsule, Delayed releaseOral	Aurobindo Pharma Limited	59651-001
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Aurobindo Pharma Limited	59651-002
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	Aurobindo Pharma Limited	59651-003
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	NuCare Pharmaceuticals,Inc.	68071-2262
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Preferred Phharmaceuticals Inc.	68788-4104
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	Bryant Ranch Prepack	71335-1851
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Bryant Ranch Prepack	71335-1852
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	Bryant Ranch Prepack	72162-2388
Omeprazole	Omeprazole 10 mg/1	Capsule, Delayed releaseOral	Proficient Rx LP	82804-280
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Northwind Health Company, LLC	82868-043