Over-the-counter drug · NDA
TopCare Omeprazole delayed release (Omeprazole) NDC 36800-121
Omeprazole 20 mg/1 · Tablet, Delayed release · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-121-01 | 3680001210136800012101 | 1 BOTTLE in 1 CARTON (36800-121-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Feb 17, 2016 | |
| 36800-121-03 | 3680001210336800012103 | 3 BOTTLE in 1 CARTON (36800-121-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Feb 2, 2016 |
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)
- TopCare Omeprazole delayed release
- Generic name (nonproprietary)
- omeprazole
- Active ingredients
- Omeprazole — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Topco Associates LLCNDC labeler code 36800
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022032
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 36800-121_f384bca8-e266-489a-8d87-3df17e7d0a56SPL ID f384bca8-e266-489a-8d87-3df17e7d0a56SPL set ID 8ed57521-e69a-4563-9ce2-4f6d667f065dRxCUI 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
N436800012101followed by a unit qualifier and the quantityPackage 36800-0121-01. 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.
About NDC 36800-121
- What is NDC 36800-121?
- 36800-121 is the product NDC for TopCare Omeprazole delayed release, Omeprazole 20 mg/1 tablet, delayed release, listed with the FDA by Topco Associates LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- TopCare Omeprazole delayed release (Omeprazole).
- What is the active ingredient?
- Omeprazole.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for TopCare Omeprazole delayed release?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 022032
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 |
|---|---|---|---|---|
| 24 hr omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Meijer, Inc. | 79481-0075 |
| basic care omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Amazon.com Services LLC | 72288-047 |
| basic care omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Amazon.com Services LLC | 72288-401 |
| basic care omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Amazon.com Services LLC | 72288-915 |
| Berkley and Jensen Omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | BJWC | 68391-915 |
| care one omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | American Sales Company | 41520-915 |
| careone omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | American Sales Company | 41520-802 |
| careone omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Retail Business Services, LLC | 72476-473 |
| dg health omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Dolgencorp Inc | 55910-215 |
| dg health omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Dolgencorp Inc | 55910-712 |
| dg health omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Dolgencorp, LLC | 55910-915 |
| equaline omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | United Natural Foods, Inc. dba UNFI | 41163-915 |
| equate omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Wal-Mart Stores Inc | 49035-119 |
| equate omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | WALMART INC. | 79903-113 |
| Equate omeprazole delayed release acid reduceromeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Wal-Mart Stores Inc | 49035-915 |
| exchange select omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Army & Air Force Exchange Service | 55301-915 |
| foster and thrive omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Strategic Sourcing Services LLC | 70677-1104 |
| foster and thrive omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Strategic Sourcing Services LLC | 70677-1275 |
| good neighbor pharmacy omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Amerisource Bergen | 46122-029 |
| good neighbor pharmacy omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Amerisource Bergen | 46122-281 |
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