What is NDC 43353-829?

43353-829 is the product NDC for Omeprazole, Omeprazole 40 mg/1 capsule, delayed release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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 43353-829 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43353-829Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43353-0829Add 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	Copy
43353-829-60	43353082960	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43353-829-60)Marketed from Mar 25, 2013
43353-829-80	43353082980	180 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43353-829-80)Marketed from Nov 11, 2020

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 — 40 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075410
Marketing start: Jan 23, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 43353-829_1b00384a-efea-458c-8485-5da3db9d28d6SPL ID 1b00384a-efea-458c-8485-5da3db9d28d6SPL set ID 4b188d97-f1b3-468d-9818-b8333bf24b5aRxCUI 200329UNII 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

N443353082960 followed by a unit qualifier and the quantity

Package 43353-0829-60. 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 Dec 17, 2020.

Indications (excerpt from the label)

Omeprazole Delayed-Release Capsules is a proton pump inhibitor indicated for: Treatment in adults of duodenal ulcer ( 1.1 ) and gastric ulcer ( 1.2 ). Treatment in adults and children of gastroesophageal reflux disease (GERD) ( 1.3 ) and maintenance of healing of erosive esophagitis ( 1.4 ). The safety and effectiveness of Omeprazole Delayed-Release Capsules in pediatric patients < 1 year of age have not been established ( 8.4 ). 1.1 Duodenal Ulcer (adults) Omeprazole Delayed-Release Capsules is indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. Omeprazole Delayed-Release …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43353-829

What is NDC 43353-829?: 43353-829 is the product NDC for Omeprazole, Omeprazole 40 mg/1 capsule, delayed release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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 075410

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

FDA NDC Directory listings under ANDA 075410
Product	Strength	Form · route	Labeler	Product NDC
Omeprazole	Omeprazole 10 mg/1	Capsule, Delayed releaseOral	Chartwell RX, LLC	62135-530
Omeprazole	Omeprazole 10 mg/1	Capsule, Delayed releaseOral	Lannett Company, Inc.	62175-114
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Lannett Company, Inc.	62175-118
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	Lannett Company, Inc.	62175-136
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	NuCare Pharmaceuticals,Inc.	68071-2243
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	NuCare Pharmaceuticals,Inc.	68071-4025
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	NuCare Pharmaceuticals,Inc.	68071-4906
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	Proficient Rx LP	71205-157
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	Bryant Ranch Prepack	71335-1532
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Bryant Ranch Prepack	71335-1746
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-155