Prescription drug · ANDA
Esomeprazole Sodium NDC 55150-185
Esomeprazole sodium 40 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-185-05 | 55150018505 | 10 VIAL in 1 CARTON (55150-185-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Aug 10, 2016 |
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 Sodium
- Generic name (nonproprietary)
- esomeprazole sodium
- Active ingredients
- Esomeprazole sodium — 40 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Eugia US LLCNDC labeler code 55150
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204657
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 55150-185_0f4cf0d6-61e7-429c-8658-e885e3c09b4aSPL ID 0f4cf0d6-61e7-429c-8658-e885e3c09b4aSPL set ID 45a15ba2-2aae-4edc-beaa-4a2357d87f32RxCUI 486501UNII L2C9GWQ43H
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N455150018505followed by a unit qualifier and the quantityPackage 55150-0185-05. 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 sodium for injection is a proton pump inhibitor (PPI) indicated for the: Short-term treatment of Gastroesophageal Reflux Disease (GERD) with erosive esophagitis (EE) in adults and pediatric patients 1 month to 17 years of age, as an alternative to oral therapy when oral esomeprazole is not possible or appropriate. ( 1.1 ) Risk reduction of rebleeding of gastric or duodenal ulcers following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers in adults. ( 1.2 ) 1.1 Treatment of Gastroesophageal Reflux Disease (GERD) with Erosive Esophagitis (EE) Esomeprazole sodium for injection is indicated for the short-term treatment of GERD with EE in adults and pediatric patie…
Excerpt only. Read the full label for complete information.
About NDC 55150-185
- What is NDC 55150-185?
- 55150-185 is the product NDC for Esomeprazole Sodium, Esomeprazole sodium 40 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Eugia US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Esomeprazole Sodium.
- What is the active ingredient?
- Esomeprazole sodium.
- Who is the labeler?
- Eugia US LLC, NDC labeler code 55150. 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 Sodium?
- 3 other product NDCs are listed under this name. See all Esomeprazole Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Esomeprazole Sodium 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 sodium | Esomeprazole sodium 40 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Slate Run Pharmaceuticals, LLC | 70436-190 | 70436-0190-82 |
| Esomeprazole Sodium | Esomeprazole sodium 20 mg/5mL | InjectionIntravenous | Gland Pharma Limited | 68083-451 | 68083-0451-10 |
| Esomeprazole Sodium | Esomeprazole sodium 40 mg/5mL | InjectionIntravenous | Gland Pharma Limited | 68083-452 | 68083-0452-10 |