Over-the-counter drug · ANDA
Esomeprazole magnesium NDC 49483-718
Esomeprazole magnesium 20 mg/1 · Capsule, Delayed release · Oral · TIME CAP LABORATORIES, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-718-41 | 49483071841 | 3 BOTTLE in 1 CARTON (49483-718-41) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Nov 14, 2023 |
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
- TIME CAP LABORATORIES, INC.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217264
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 49483-718_08ad180e-e87a-ba6f-e063-6394a90a2bc7SPL ID 08ad180e-e87a-ba6f-e063-6394a90a2bc7SPL set ID 08acf79f-f50d-8416-e063-6294a90a2704RxCUI 606726UNII R6DXU4WAY9UPC 0349483718416
- 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
N449483071841followed by a unit qualifier and the quantityPackage 49483-0718-41. 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)
Uses 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 217264
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 Delayed Releaseesomeprazole magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | WALGREENS | 0363-7810 |
| Esomeprazole Magnesium Delayed-Release Capsules, 20 mg | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | MARKSANS PHARMA LIMITED | 25000-075 |
| Esomeprazole Magnesium Delayed-Release 20 mg (OTC) | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | MARKSANS PHARMA LIMITED | 25000-088 |
| Esomeprazole magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | BETTER LIVING BRANDS, LLC | 21130-718 |
| Esomeprazole Magnesium Delayed Release 20 mg mini | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | MARKSANS PHARMA LIMITED | 25000-096 |
| Esomeprazole Magnesium Delayed-Release 20 mg mini | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | MARKSANS PHARMA LIMITED | 25000-112 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Walmart Inc. | 79903-382 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | H-E-B | 37808-646 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | BETTER LIVING BRANDS LLC. | 21130-257 |
| 24 HOUR Esomeprazole Magnesiumesomeprazole magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Grocery Outlet, Inc. | 85828-718 |