Over-the-counter drug · ANDA
leader esomeprazole magnesium (Esomeprazole) NDC 70000-0727
Esomeprazole 20 mg/1 · Capsule, Delayed release · Oral · Cardinal Health 110, LLC. dba Leader
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0727-1 | 70000072701 | 3 BOTTLE in 1 CARTON (70000-0727-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Apr 23, 2025 | |
| 70000-0727-2 | 70000072702 | 1 BOTTLE in 1 CARTON (70000-0727-2) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Apr 2, 2025 |
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)
- leader esomeprazole magnesium
- Generic name (nonproprietary)
- esomeprazole
- Active ingredients
- Esomeprazole — 20 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Cardinal Health 110, LLC. dba LeaderNDC labeler code 70000
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207193
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 70000-0727_70bfe4f8-4dba-4b46-abbd-7ff48928c9d5SPL ID 70bfe4f8-4dba-4b46-abbd-7ff48928c9d5SPL set ID c9472b82-d345-4531-bf07-bd55c94876abRxCUI 606726UNII N3PA6559FT
- 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
N470000072701followed by a unit qualifier and the quantityPackage 70000-0727-01. 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)
Uses • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
Excerpt only. Read the full label for complete information.
About NDC 70000-0727
- What is NDC 70000-0727?
- 70000-0727 is the product NDC for leader esomeprazole magnesium (esomeprazole), Esomeprazole 20 mg/1 capsule, delayed release, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- leader esomeprazole magnesium (Esomeprazole).
- What is the active ingredient?
- Esomeprazole.
- Who is the labeler?
- Cardinal Health 110, LLC. dba Leader, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for leader esomeprazole magnesium?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 207193
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 | Esomeprazole 20 mg/1 | Capsule, Delayed releaseOral | Meijer Distribution Inc | 41250-900 |
| Up and Up Esomeprazole Magnesiumesomeprazole magnesium | Esomeprazole magnesium dihydrate 20 mg/1 | Capsule, Delayed releaseOral | Target Corporation | 11673-753 |
| esomeprazole magnesiumesomeprazole magnesium dihydrate | Esomeprazole magnesium dihydrate 20 mg/1 | Capsule, Delayed releaseOral | HyVee Inc | 42507-774 |
| Exchange Select Esomeprazole Magnesiumesomeprazole | Esomeprazole 20 mg/1 | Capsule, Delayed releaseOral | Army & Air Force Exchange Service | 55301-898 |
| careone esomeprazole magnesiumesomeprazole | Esomeprazole 20 mg/1 | Capsule, Delayed releaseOral | American Sales Company | 41520-727 |
| DG Health Esomeprazole Magnesiumesomeprazole | Esomeprazole 20 mg/1 | Capsule, Delayed releaseOral | Dolgencorp Inc | 55910-593 |
| kirkland signature esomeprazole magnesiumesomeprazole | Esomeprazole 20 mg/1 | Capsule, Delayed releaseOral | Costco Wholesale Company | 63981-898 |
| esomeprazole magnesiumesomeprazole | Esomeprazole 20 mg/1 | Capsule, Delayed releaseOral | Walgreen Company | 0363-7223 |
| esomeprazole magnesiumesomeprazole magnesium dihydrate | Esomeprazole magnesium dihydrate 20 mg/1 | Capsule, Delayed releaseOral | Amazon.com Services LLC | 72288-780 |
| esomeprazole magnesiumesomeprazole | Esomeprazole 20 mg/1 | Capsule, Delayed releaseOral | HyVee Inc | 42507-898 |
| dg health esomeprazole magnesiumesomeprazole | Esomeprazole 20 mg/1 | Capsule, Delayed releaseOral | Dolgencorp Inc | 55910-640 |
| topcare esomeprazole magnesiumesomeprazole magnesium | Esomeprazole magnesium dihydrate 20 mg/1 | Capsule, Delayed releaseOral | Topco Associates LLC | 36800-627 |
| good sense esomeprazole magnesiumesomeprazole | Esomeprazole 20 mg/1 | Capsule, Delayed releaseOral | L. Perrigo Company | 0113-2022 |
| signature care esomeprazole magnesiumesomeprazole | Esomeprazole 20 mg/1 | Capsule, Delayed releaseOral | Safeway | 21130-714 |
| basic care esomeprazole magnesiumesomeprazole | Esomeprazole 20 mg/1 | Capsule, Delayed releaseOral | Amazon.com Services LLC | 72288-898 |
| signature care esomeprazole magnesiumesomeprazole | Esomeprazole 20 mg/1 | Capsule, Delayed releaseOral | Safeway | 21130-088 |
| up and up esomeprazole magnesiumesomeprazole | Esomeprazole 20 mg/1 | Capsule, Delayed releaseOral | Target Corporation | 11673-898 |
| esomeprazole magnesiumesomeprazole | Esomeprazole 20 mg/1 | Capsule, Delayed releaseOral | Kroger Company | 30142-273 |
| Esomeprazole Magnesiumesomeprazole magnesium dihydrate | Esomeprazole 20 mg/1 | Capsule, Delayed releaseOral | Walgreen Company | 0363-1699 |
| Good Sense Esomeprazole Magnesiumesomeprazole | Esomeprazole 20 mg/1 | Capsule, Delayed releaseOral | L. Perrigo Company | 0113-0898 |
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