Prescription drug · ANDA
esomeprazole magnesium NDC 70771-1494
Esomeprazole magnesium dihydrate 40 mg/1 · Capsule, Delayed release · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1494-0 | 70771149400 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70771-1494-0)Marketed from May 30, 2019 | |
| 70771-1494-3 | 70771149403 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70771-1494-3)Marketed from May 30, 2019 | |
| 70771-1494-9 | 70771149409 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70771-1494-9)Marketed from May 30, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 40 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206296
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 70771-1494_7452a5f1-8acc-4d3b-a69f-c9b73d97f09bSPL ID 7452a5f1-8acc-4d3b-a69f-c9b73d97f09bSPL set ID 6f314f5d-453c-4876-b9b8-20663008dfb1RxCUI 606726, 606730UNII 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
N470771149400followed by a unit qualifier and the quantityPackage 70771-1494-00. 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 .
About NDC 70771-1494
- What is NDC 70771-1494?
- 70771-1494 is the product NDC for esomeprazole magnesium, Esomeprazole magnesium dihydrate 40 mg/1 capsule, delayed release, listed with the FDA by Zydus Lifesciences Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- esomeprazole magnesium.
- What is the active ingredient?
- Esomeprazole magnesium dihydrate.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for esomeprazole magnesium?
- 174 other product NDCs are listed under this name. See all esomeprazole magnesium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other esomeprazole magnesium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | St. Mary's Medical Park Pharmacy | 60760-877 | 60760-0877-60 |
| Esomeprazole Magnesiumesomeprazole | Esomeprazole 20 mg/1 | Capsule, Delayed releaseOral | Amazon.com Services LLC | 72288-563 | 72288-0563-01 |
| esomeprazole magnesiumesomeprazole magnesium dihydrate | Esomeprazole magnesium dihydrate 20 mg/1 | Capsule, Delayed releaseOral | Amazon.com Services LLC | 72288-780 | 72288-0780-03 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | American Health Packaging | 60687-934 | 60687-0934-21 |
| esomeprazole magnesiumesomeprazole | Esomeprazole 20 mg/1 | Capsule, Delayed releaseOral | Amazon.com Services LLC | 72288-669 | 72288-0669-0172288-0669-03 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | H-E-B | 37808-646 | 37808-0646-4137808-0646-4537808-0646-82 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Rising Pharma Holdings, Inc. | 64980-664 | 64980-0664-1964980-0664-41 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | CapsuleOral | YYBA CORP | 73581-014 | 73581-0014-42 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | AvPAK | 50268-272 | 50268-0272-13 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-4581 | 70518-4581-00 |
Other NDCs under ANDA 206296
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 20 mg/1 | Capsule, Delayed releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-441 |
| esomeprazole magnesium | Esomeprazole magnesium dihydrate 40 mg/1 | Capsule, Delayed releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-442 |
| esomeprazole magnesium | Esomeprazole magnesium dihydrate 20 mg/1 | Capsule, Delayed releaseOral | Zydus Lifesciences Limited | 70771-1493 |
| esomeprazole magnesium | Esomeprazole magnesium dihydrate 40 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-1335 |
| esomeprazole magnesium | Esomeprazole magnesium dihydrate 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-1368 |