Over-the-counter drug · NDA
Nexium 24HR ClearMinis (Esomeprazole magnesium) NDC 0573-2452
Esomeprazole magnesium 20 mg/1 · Capsule, Delayed release · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0573-2452-02 | 00573245202 | 1 BLISTER PACK in 1 CARTON (0573-2452-02) / 2 CAPSULE, DELAYED RELEASE in 1 BLISTER PACKMarketed from Mar 1, 2017 | |
| 0573-2452-14 | 00573245214 | 1 BOTTLE in 1 CARTON (0573-2452-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 1, 2017 | |
| 0573-2452-42 | 00573245242 | 3 BOTTLE in 1 CARTON (0573-2452-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 1, 2017 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Nexium 24HR ClearMinis
- Generic name (nonproprietary)
- esomeprazole magnesium
- Active ingredients
- Esomeprazole magnesium — 20 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Haleon US Holdings LLCNDC labeler code 0573
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204655
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 0573-2452_140967ff-7019-a38f-e063-6394a90ab708SPL ID 140967ff-7019-a38f-e063-6394a90ab708SPL set ID 4513934d-0cf0-40fc-a348-b4e75a33b094RxCUI 606726, 606728UNII 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
N400573245202followed by a unit qualifier and the quantityPackage 00573-2452-02. 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 0573-2452
- What is NDC 0573-2452?
- 0573-2452 is the product NDC for Nexium 24HR ClearMinis (esomeprazole magnesium), Esomeprazole magnesium 20 mg/1 capsule, delayed release, listed with the FDA by Haleon US Holdings LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nexium 24HR ClearMinis (Esomeprazole magnesium).
- What is the active ingredient?
- Esomeprazole magnesium.
- Who is the labeler?
- Haleon US Holdings LLC, NDC labeler code 0573. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nexium 24HR ClearMinis?
- 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 NDA 204655
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 |
|---|---|---|---|---|
| Nexium 24HResomeprazole magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Haleon US Holdings LLC | 0573-2450 |
| Nexium 24HResomeprazole magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-1492 |