Over-the-counter drug · ANDA
Esomeprazole Magnesium NDC 63868-425
Esomeprazole magnesium 20 mg/1 · Capsule, Delayed release · Oral · CHAIN DRUG MARKETING ASSOCIATION INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63868-425-14 | 63868042514 | 1 BOTTLE in 1 CARTON (63868-425-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Jul 6, 2018 | |
| 63868-425-28 | 63868042528 | 2 BOTTLE in 1 CARTON (63868-425-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 15, 2019 | |
| 63868-425-42 | 63868042542 | 3 BOTTLE in 1 CARTON (63868-425-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Jul 6, 2018 |
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 Magnesium
- Generic name (nonproprietary)
- esomeprazole magnesium
- Active ingredients
- Esomeprazole magnesium — 20 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207673
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 63868-425_241fe5f8-399c-5ac9-fc77-f078e69ecb65SPL ID 241fe5f8-399c-5ac9-fc77-f078e69ecb65SPL set ID f95053ab-d6c5-ee92-58d1-6f203873f79cRxCUI 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
N463868042514followed by a unit qualifier and the quantityPackage 63868-0425-14. 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(s) 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 207673
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 |
|---|---|---|---|---|
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Walgreens Company | 0363-3298 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Inc | 43598-407 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | The Kroger Co. | 30142-261 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | HEB | 37808-115 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Inc. | 43598-812 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Discount Drug Mart, Inc | 53943-527 |