Over-the-counter drug · ANDA
Esomeprazole (esomeprazole magnesium) NDC 51660-027
Esomeprazole magnesium 20 mg/1 · Capsule, Delayed release · Oral · Ohm Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51660-027-14 | 51660002714 | 1 BOTTLE in 1 CARTON (51660-027-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Aug 14, 2020 | |
| 51660-027-27 | 51660002727 | 2 BOTTLE in 1 CARTON (51660-027-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Aug 14, 2020 | |
| 51660-027-44 | 51660002744 | 3 BOTTLE in 1 CARTON (51660-027-44) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Aug 14, 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)
- Esomeprazole
- Generic name (nonproprietary)
- esomeprazole magnesium
- Active ingredients
- Esomeprazole magnesium — 20 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Ohm Laboratories Inc.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212866
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 51660-027_53a1652c-a8b0-ed15-e063-6394a90a0a6bSPL ID 53a1652c-a8b0-ed15-e063-6394a90a0a6bSPL set ID e6d19b0a-44a8-42fe-8a6c-717ecb3ac1c4RxCUI 606726UNII R6DXU4WAY9
- 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
N451660002714followed by a unit qualifier and the quantityPackage 51660-0027-14. 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.
Other NDCs under ANDA 212866
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 |
|---|---|---|---|---|
| Esomeprazoleesomeprazole magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | GERI-CARE PHARMACEUTICALS, CORP | 57896-740 |
| Esomeprazoleesomeprazole magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | VALU MERCHANDISERS COMPANY | 63941-999 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | LITTLE PHARMA, INC. | 72559-011 |
| esomeprazole | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | THE KROGER COMPANY | 30142-989 |
| Esomeprazoleesomeprazole magnesium | Esomeprazole magnesium 20 mg/1 | TabletOral | HARRIS TEETER | 72036-982 |
| Esomeprazoleesomeprazole magnesium | Esomeprazole magnesium trihydrate 20 mg/1 | Capsule, Delayed releaseOral | INNOVUS PHARMACEUTICALS, INC. | 57483-900 |
| Esomeprazoleesomeprazole magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | YYBA CORP | 73581-013 |
| Esomeprazole | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Safeway, Inc. | 21130-926 |
| Esomeprazoleesomeprazole magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | CVS | 51316-715 |