Prescription drug · ANDA
Esomeprazole magnesium NDC 67877-571
esomeprazole magnesium delayed release capsules · Esomeprazole magnesium 20 mg/1 · Capsule, Coated pellets · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-571-05 | 67877057105 | 500 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-05)Marketed from Feb 27, 2021 | |
| 67877-571-10 | 67877057110 | 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-10)Marketed from Feb 27, 2021 | |
| 67877-571-30 | 67877057130 | 30 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-30)Marketed from Feb 27, 2021 | |
| 67877-571-38 | 67877057138 | 10 BLISTER PACK in 1 CARTON (67877-571-38) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACKMarketed from Feb 27, 2021 | |
| 67877-571-90 | 67877057190 | 90 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-90)Marketed from Feb 27, 2021 |
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 delayed release capsules
- Active ingredients
- Esomeprazole magnesium — 20 mg/1
- Dosage form
- Capsule, Coated pellets
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210559
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 67877-571_27b22eed-c148-41cd-bdd7-434610f98b70SPL ID 27b22eed-c148-41cd-bdd7-434610f98b70SPL set ID 277ce748-2809-4be0-81e7-6a4d604f2c6fRxCUI 606726, 606730UNII R6DXU4WAY9UPC 0367877571300
- 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
N467877057105followed by a unit qualifier and the quantityPackage 67877-0571-05. 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 is a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules 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 ulcers. ( 1.4 ) Helicobacter pylori eradicatio…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210559
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 magnesiumesomeprazole magnesium delayed release capsules | Esomeprazole magnesium 40 mg/1 | Capsule, Coated pelletsOral | Asclemed USA, Inc. | 76420-227 |
| Esomeprazole magnesiumesomeprazole magnesium delayed release capsules | Esomeprazole magnesium 20 mg/1 | Capsule, Coated pelletsOral | Asclemed USA, Inc. | 76420-226 |
| Esomeprazole magnesiumesomeprazole magnesium delayed release capsules | Esomeprazole magnesium trihydrate 20 mg/1 | Capsule, Coated pelletsOral | Proficient Rx LP | 71205-706 |
| Esomeprazole magnesiumesomeprazole magnesium delayed release capsules | Esomeprazole magnesium 40 mg/1 | Capsule, Coated pelletsOral | Ascend Laboratories, LLC | 67877-572 |
| Esomeprazole magnesiumesomeprazole magnesium delayed release capsules | Esomeprazole magnesium 20 mg/1 | Capsule, Coated pelletsOral | Bryant Ranch Prepack | 71335-9678 |