Prescription drug · ANDA
Esomeprazole magnesium NDC 69097-508
Esomeprazole magnesium dihydrate 5 mg/1 · For suspension · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-508-31 | 6909705083169097050831 | 30 FOR SUSPENSION in 1 CARTON (69097-508-31)Marketed from Jan 7, 2025 |
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 — 5 mg/1
- Dosage form
- For suspension
- Route
- Oral
- Labeler
- Cipla USA Inc.NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217714
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 69097-508_75c5150c-7eab-4f85-9c34-80c0ecb4a07bSPL ID 75c5150c-7eab-4f85-9c34-80c0ecb4a07bSPL set ID e89589f1-945e-429a-819e-61755cba77faRxCUI 1297658, 1297761UNII 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
N469097050831followed by a unit qualifier and the quantityPackage 69097-0508-31. 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 is indicated for the: Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 1 year 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 ul…
Excerpt only. Read the full label for complete information.
About NDC 69097-508
- What is NDC 69097-508?
- 69097-508 is the product NDC for Esomeprazole magnesium, Esomeprazole magnesium dihydrate 5 mg/1 for suspension, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, 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?
- Cipla USA Inc., NDC labeler code 69097. 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 217714
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 2.5 mg/1 | For suspensionOral | Cipla USA Inc. | 69097-507 |