Over-the-counter drug · ANDA
Esomeprazole Magnesium NDC 64980-664
Esomeprazole magnesium 20 mg/1 · Capsule, Delayed release · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-664-19 | 64980066419 | 3 BOTTLE in 1 CARTON (64980-664-19) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from May 30, 2026 | |
| 64980-664-41 | 64980066441 | 1 BOTTLE in 1 CARTON (64980-664-41) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from May 30, 2026 |
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
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216349
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 64980-664_b0715b2b-3453-4088-891d-91a1aa22f57dSPL ID b0715b2b-3453-4088-891d-91a1aa22f57dSPL set ID 2164e1d7-e601-4ce5-be29-0c21c3a5a647RxCUI 606726UNII R6DXU4WAY9UPC 0364980664196, 0364980664417
- 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
N464980066419followed by a unit qualifier and the quantityPackage 64980-0664-19. 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 .
Other NDCs under ANDA 216349
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 | GLENMARK THERAPEUTICS INC., USA | 72657-124 |
| esomeprazole magnesium | Esomeprazole magnesium trihydrate 20 mg/1 | Capsule, Delayed releaseOral | GLENMARK THERAPEUTICS INC., USA | 72657-127 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Reliable 1 Laboratories LLC | 69618-073 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Rising Pharma Holdings, Inc. | 16571-880 |