Over-the-counter drug · NDA
Signature Care Omeprazole (Omeprazole) NDC 21130-128
Omeprazole 20 mg/1 · Tablet, Orally disintegrating, Delayed release · Oral · Safeway
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21130-128-55 | 2113001285521130012855 | 3 CARTON in 1 CARTON (21130-128-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACKMarketed from Jul 11, 2018 | |
| 21130-128-74 | 2113001287421130012874 | 14 BLISTER PACK in 1 CARTON (21130-128-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACKMarketed from Jul 2, 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)
- Signature Care Omeprazole
- Generic name (nonproprietary)
- omeprazole
- Active ingredients
- Omeprazole — 20 mg/1
- Dosage form
- Tablet, Orally disintegrating, Delayed release
- Route
- Oral
- Labeler
- SafewayNDC labeler code 21130
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209400
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 21130-128_eb0dd73c-7d2d-424f-a939-dcdb18ee21f1SPL ID eb0dd73c-7d2d-424f-a939-dcdb18ee21f1SPL set ID c76c4235-92d4-4384-8ddc-ceed0b928c48RxCUI 2003656UNII 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
N421130012855followed by a unit qualifier and the quantityPackage 21130-0128-55. 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 21130-128
- What is NDC 21130-128?
- 21130-128 is the product NDC for Signature Care Omeprazole (omeprazole), Omeprazole 20 mg/1 tablet, orally disintegrating, delayed release, listed with the FDA by Safeway. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Signature Care Omeprazole (Omeprazole).
- What is the active ingredient?
- Omeprazole.
- Who is the labeler?
- Safeway, NDC labeler code 21130. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Signature Care Omeprazole?
- 2 other product NDCs are listed under this name. See all Signature Care Omeprazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Signature Care 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) |
|---|---|---|---|---|---|
| signature care omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Safeway | 21130-401 | 21130-0401-0121130-0401-03 |
| Signature Care Omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Safeway | 21130-137 | 21130-0137-5521130-0137-74 |
Other NDCs under NDA 209400
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 |
|---|---|---|---|---|
| Basic Care Omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Amazon.com Services LLC | 72288-123 |
| berkley and jensen omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | BJWC | 68391-103 |
| careone omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | American Sales Company | 41520-939 |
| DG health omperazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Dolgencorp Inc | 55910-713 |
| equaline omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | United Natural Foods, Inc. dba UNFI | 41163-634 |
| good neighbor pharmacy omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Amerisource Bergen | 46122-616 |
| good sense omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | L. Perrigo Company | 0113-0520 |
| Leader Omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Cardinal Health 110, LLC. dba Leader | 70000-0381 |
| omeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Walgreen Company | 0363-1819 |
| omeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Kroger Company | 30142-394 |
| omeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | H E B | 37808-354 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Meijer Distribution Inc | 41250-349 |
| omeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | HyVee Inc | 42507-164 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | CVS Pharmacy | 69842-791 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Amazon.com Services LLC | 72288-666 |
| topcare omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Topco Associates LLC | 36800-601 |
| up and up omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Target Corporation | 11673-212 |