Prescription drug · ANDA
esomeprazole magnesium NDC 70377-055
Esomeprazole magnesium 20 mg/1 · Capsule, Delayed release · Oral · Biocon Pharma Inc.,
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70377-055-11 | 7037700551170377005511 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-055-11)Marketed from Mar 19, 2021 | |
| 70377-055-12 | 7037700551270377005512 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-055-12)Marketed from Mar 19, 2021 | |
| 70377-055-13 | 7037700551370377005513 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-055-13)Marketed from Mar 19, 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
- Active ingredients
- Esomeprazole magnesium — 20 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Biocon Pharma Inc.,NDC labeler code 70377
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213486
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 70377-055_b4ff12a6-841e-4eff-b9a4-bb814230eea5SPL ID b4ff12a6-841e-4eff-b9a4-bb814230eea5SPL set ID 66c9e2bf-2dc4-4683-89fd-6dadf1b01ee9RxCUI 606726, 606730UNII R6DXU4WAY9UPC 0370377055119
- 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
N470377005511followed by a unit qualifier and the quantityPackage 70377-0055-11. 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 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 eradication in adult…
Excerpt only. Read the full label for complete information.
About NDC 70377-055
- What is NDC 70377-055?
- 70377-055 is the product NDC for esomeprazole magnesium, Esomeprazole magnesium 20 mg/1 capsule, delayed release, listed with the FDA by Biocon Pharma Inc.,. 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.
- Who is the labeler?
- Biocon Pharma Inc.,, NDC labeler code 70377. 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?
- 179 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 | REMEDYREPACK INC. | 70518-4776 | 70518-4776-00 |
| Esomeprazole Magnesium | Esomeprazole magnesium dihydrate 20 mg/1 | Capsule, Delayed releaseOral | Chain Drug Marketing Association, Inc. | 83324-328 | 83324-0328-1483324-0328-42 |
| 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 |
Other NDCs under ANDA 213486
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 | NuCare Pharmaceuticals,Inc. | 68071-3419 |
| esomeprazole magnesium | Esomeprazole magnesium trihydrate 40 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-8524 |
| esomeprazole magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Biocon Pharma Inc., | 70377-056 |
| esomeprazole magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-3850 |
| esomeprazole magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-2476 |
| esomeprazole magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-9713 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Quallent Pharmaceuticals Health LLC | 82009-033 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Quallent Pharmaceuticals Health LLC | 82009-034 |
| esomeprazole magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 82804-078 |