Prescription drug · ANDA
Esomeprazole Magnesium NDC 68382-848
Esomeprazole magnesium dihydrate 20 mg/1 · Granule, Delayed release · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-848-94 | 68382084894 | 30 GRANULE, DELAYED RELEASE in 1 CARTON (68382-848-94)Marketed from Jun 30, 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 dihydrate — 20 mg/1
- Dosage form
- Granule, Delayed release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206055
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 68382-848_bc31956a-671b-4ca3-b9dd-1fdb03003caeSPL ID bc31956a-671b-4ca3-b9dd-1fdb03003caeSPL set ID 190a4c5b-1547-45d7-b00b-10da4131e2e2RxCUI 692576, 692578UNII 36H71644EQ
- 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
N468382084894followed by a unit qualifier and the quantityPackage 68382-0848-94. 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)
Esomeprazole magnesium for delayed-release oral suspension is a proton pump inhibitor (PPI). Esomeprazole magnesium for delayed-release oral suspension are indicated for the: Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1 ) Maintenance of healing of EE in adults. ( 1.2 ) Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3 ) Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206055
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 dihydrate 40 mg/1 | Granule, Delayed releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-849 |
| Esomeprazole Magnesium | Esomeprazole magnesium dihydrate 20 mg/1 | Granule, Delayed releaseOral | Zydus Lifesciences Limited | 70771-1391 |
| Esomeprazole Magnesium | Esomeprazole magnesium dihydrate 40 mg/1 | Granule, Delayed releaseOral | Zydus Lifesciences Limited | 70771-1392 |