NDC codes

FDA NDC Directory
Product NDC (as listed)70436-190Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70436-0190Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70436-190-82704360190827043601908210 VIAL in 1 CARTON (70436-190-82) / 5 mL in 1 VIAL (70436-190-80)Marketed from Feb 25, 2022

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/5mL
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous
Labeler
Slate Run Pharmaceuticals, LLCNDC labeler code 70436
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215732
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 70436-190_54e3fe0f-b6a6-6b5d-e063-6294a90a836aSPL ID 54e3fe0f-b6a6-6b5d-e063-6294a90a836aSPL set ID 23395673-116d-4a8e-b0ce-59f9ca5b3dafRxCUI 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.

How CPT relates to drug billing

NDC on a medical claim

N470436019082 followed by a unit qualifier and the quantity

Package 70436-0190-82. 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 patients …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70436-190

What is NDC 70436-190?
70436-190 is the product NDC for Esomeprazole sodium, Esomeprazole sodium 40 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Slate Run Pharmaceuticals, 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?
Slate Run Pharmaceuticals, LLC, NDC labeler code 70436. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Esomeprazole sodium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Esomeprazole SodiumEsomeprazole sodium 20 mg/5mLInjectionIntravenousGland Pharma Limited68083-45168083-0451-10
Esomeprazole SodiumEsomeprazole sodium 40 mg/5mLInjectionIntravenousGland Pharma Limited68083-45268083-0452-10
Esomeprazole SodiumEsomeprazole sodium 40 mg/1Injection, Powder, Lyophilized, For solutionIntravenousEugia US LLC55150-18555150-0185-05

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