What is NDC 68083-452?

68083-452 is the product NDC for Esomeprazole Sodium, Esomeprazole sodium 40 mg/5mL injection, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Esomeprazole Sodium NDC 68083-452 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-452Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0452Add 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 NDC	11-digit (billing)	Package	Copy
68083-452-10	68083045210	10 VIAL in 1 CARTON (68083-452-10) / 5 mL in 1 VIAL (68083-452-01)Marketed from Apr 1, 2020

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
Route: Intravenous
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203349
Marketing start: Apr 1, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 68083-452_e8d62781-b9de-4d02-b5d2-02b024895c95SPL ID e8d62781-b9de-4d02-b5d2-02b024895c95SPL set ID 9354958c-e997-41c8-8605-23f0a58993c0RxCUI 486499, 486501UNII L2C9GWQ43HUPC 0368083452100
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

N468083045210 followed by a unit qualifier and the quantity

Package 68083-0452-10. 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 Jul 21, 2023.

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 sodium 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 pedi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-452

What is NDC 68083-452?: 68083-452 is the product NDC for Esomeprazole Sodium, Esomeprazole sodium 40 mg/5mL injection, listed with the FDA by Gland Pharma Limited. 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?: Gland Pharma Limited, NDC labeler code 68083. 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
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/1	Injection, Powder, Lyophilized, For solutionIntravenous	Eugia US LLC	55150-185	55150-0185-05

Other NDCs under ANDA 203349

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203349
Product	Strength	Form · route	Labeler	Product NDC
Esomeprazole Sodium	Esomeprazole sodium 20 mg/5mL	InjectionIntravenous	Gland Pharma Limited	68083-451