Prescription drug · NDA
Nexium (Esomeprazole magnesium) NDC 0186-5040
Esomeprazole magnesium trihydrate 40 mg/1 · Capsule, Delayed release · Oral · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0186-5040-31 | 00186504031 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5040-31)Marketed from Mar 19, 2001 | |
| 0186-5040-54 | 00186504054 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5040-54)Marketed from Mar 19, 2001 |
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
- Generic name (nonproprietary)
- esomeprazole magnesium
- Active ingredients
- Esomeprazole magnesium trihydrate — 40 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- AstraZeneca Pharmaceuticals LPNDC labeler code 0186
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021153
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 0186-5040_26f66e74-b652-4b1d-bfff-62a3cc87d590SPL ID 26f66e74-b652-4b1d-bfff-62a3cc87d590SPL set ID f4853677-1622-4037-688b-fdf533a11d96RxCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, 1297658, 1297660, 1297761, 1297763UNII 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
N400186504031followed by a unit qualifier and the quantityPackage 00186-5040-31. 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)
NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension 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 ) • Helic…
Excerpt only. Read the full label for complete information.
About NDC 0186-5040
- What is NDC 0186-5040?
- 0186-5040 is the product NDC for Nexium (esomeprazole magnesium), Esomeprazole magnesium trihydrate 40 mg/1 capsule, delayed release, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nexium (Esomeprazole magnesium).
- What is the active ingredient?
- Esomeprazole magnesium trihydrate.
- Who is the labeler?
- AstraZeneca Pharmaceuticals LP, NDC labeler code 0186. 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?
- 6 other product NDCs are listed under this name. See all Nexium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nexium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nexiumesomeprazole magnesium | Esomeprazole magnesium trihydrate 2.5 mg/1 | Granule, Delayed releaseOral | AstraZeneca Pharmaceuticals LP | 0186-4025 | 00186-4025-01 |
| Nexiumesomeprazole magnesium | Esomeprazole magnesium trihydrate 5 mg/1 | Granule, Delayed releaseOral | AstraZeneca Pharmaceuticals LP | 0186-4050 | 00186-4050-01 |
| Nexiumesomeprazole magnesium | Esomeprazole magnesium trihydrate 10 mg/1 | Granule, Delayed releaseOral | AstraZeneca Pharmaceuticals LP | 0186-4010 | 00186-4010-01 |
| Nexiumesomeprazole magnesium | Esomeprazole magnesium trihydrate 20 mg/1 | Granule, Delayed releaseOral | AstraZeneca Pharmaceuticals LP | 0186-4020 | 00186-4020-01 |
| Nexiumesomeprazole magnesium | Esomeprazole magnesium trihydrate 40 mg/1 | Granule, Delayed releaseOral | AstraZeneca Pharmaceuticals LP | 0186-4040 | 00186-4040-01 |
| Nexiumesomeprazole magnesium | Esomeprazole magnesium trihydrate 20 mg/1 | Capsule, Delayed releaseOral | AstraZeneca Pharmaceuticals LP | 0186-5020 | 00186-5020-3100186-5020-54 |
Other NDCs under NDA 021153
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 |
|---|---|---|---|---|
| Nexiumesomeprazole magnesium | Esomeprazole magnesium trihydrate 20 mg/1 | Capsule, Delayed releaseOral | AstraZeneca Pharmaceuticals LP | 0186-5020 |