Over-the-counter drug · ANDA
Omeprazole NDC 69230-318
Omeprazole 20 mg/1 · Tablet, Delayed release · Oral · Camber Consumer Care Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69230-318-05 | 6923003180569230031805 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (69230-318-05)Marketed from Oct 29, 2020 | |
| 69230-318-10 | 6923003181069230031810 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (69230-318-10)Marketed from Oct 29, 2020 | |
| 69230-318-32 | 6923003183269230031832 | 1 BLISTER PACK in 1 CARTON (69230-318-32) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Mar 25, 2020 | |
| 69230-318-33 | 6923003183369230031833 | 2 BLISTER PACK in 1 CARTON (69230-318-33) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Mar 25, 2020 | |
| 69230-318-34 | 6923003183469230031834 | 3 BLISTER PACK in 1 CARTON (69230-318-34) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Mar 25, 2020 | |
| 69230-318-35 | 6923003183569230031835 | 1 BOTTLE in 1 CARTON (69230-318-35) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 25, 2020 | |
| 69230-318-36 | 6923003183669230031836 | 2 BOTTLE in 1 CARTON (69230-318-36) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 25, 2020 | |
| 69230-318-37 | 6923003183769230031837 | 3 BOTTLE in 1 CARTON (69230-318-37) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 25, 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 — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Camber Consumer Care IncNDC labeler code 69230
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211732
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 69230-318_ee873df8-2b35-9bc7-e053-2a95a90a0f83SPL ID ee873df8-2b35-9bc7-e053-2a95a90a0f83SPL set ID 9c856d3a-e38f-4006-a43a-ec1a9fa0f057RxCUI 402014UNII KG60484QX9UPC 0369230318355
- 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
N469230031805followed by a unit qualifier and the quantityPackage 69230-0318-05. 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.
About NDC 69230-318
- What is NDC 69230-318?
- 69230-318 is the product NDC for Omeprazole, Omeprazole 20 mg/1 tablet, delayed release, listed with the FDA by Camber Consumer Care Inc. It has 8 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?
- Camber Consumer Care Inc, NDC labeler code 69230. 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.
Related NDCs: other Omeprazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Omeprazole | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Chain Drug Marketing Association, Inc. | 83324-309 | 83324-0309-1483324-0309-42 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Amazon.com Services LLC | 72288-666 | 72288-0666-5572288-0666-74 |
| 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 | Discount Drug Mart, Inc | 53943-038 | 53943-0038-1453943-0038-42 |
| 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 |
Other NDCs under ANDA 211732
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| GoodMeds 24HR Acid Reducer Omeprazole 20mgomeprazole 20mg | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Cabinet Health P.B.C. | 82725-4052 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-6888 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Allegiant Health | 69168-476 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-011 |