Prescription drug · ANDA
Esomeprazole Magnesium NDC 71335-2040
Esomeprazole magnesium 40 mg/1 · Capsule, Delayed release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2040-1 | 71335204001 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2040-1)Marketed from Mar 3, 2022 | |
| 71335-2040-2 | 71335204002 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2040-2)Marketed from Apr 20, 2022 | |
| 71335-2040-3 | 71335204003 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2040-3)Marketed from Feb 22, 2022 | |
| 71335-2040-4 | 71335204004 | 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2040-4)Marketed from Aug 12, 2024 | |
| 71335-2040-5 | 71335204005 | 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2040-5)Marketed from Jul 13, 2023 | |
| 71335-2040-6 | 71335204006 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2040-6)Marketed from Aug 12, 2024 | |
| 71335-2040-7 | 71335204007 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2040-7)Marketed from Jan 26, 2023 |
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 — 40 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211977
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-2040_3688c82f-b564-4f5c-b916-617310c93f70SPL ID 3688c82f-b564-4f5c-b916-617310c93f70SPL set ID 61cc0020-aab8-42a3-b0a6-93062f382c87RxCUI 606730UNII R6DXU4WAY9
- 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
N471335204001followed by a unit qualifier and the quantityPackage 71335-2040-01. 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 delayed-release capsules are 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.…
Excerpt only. Read the full label for complete information.
About NDC 71335-2040
- What is NDC 71335-2040?
- 71335-2040 is the product NDC for Esomeprazole Magnesium, Esomeprazole magnesium 40 mg/1 capsule, delayed release, listed with the FDA by Bryant Ranch Prepack. It has 7 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?
- Bryant Ranch Prepack, NDC labeler code 71335. 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?
- 181 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 211977
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 40 mg/1 | Capsule, Delayed releaseOral | Direct Rx | 72189-318 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-2018 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7896 |
| Esomeprazole DR | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Direct_Rx | 72189-381 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7360 |
| Esomeprazole Magnesium DResomeprazole magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0331 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | American Health Packaging | 60687-934 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-4581 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0419 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0420 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Asclemed USA, Inc. | 76420-904 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Asclemed USA, Inc. | 76420-905 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | St. Mary's Medical Park Pharmacy | 60760-877 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Camber Pharmaceuticals, Inc. | 31722-664 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Camber Pharmaceuticals, Inc. | 31722-665 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-6198 |