What is NDC 68083-614?

68083-614 is the product NDC for Chlorothiazide sodium, Chlorothiazide sodium 500 mg/18mL injection, powder, lyophilized, for solution, 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 Chlorothiazide 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.

Chlorothiazide sodium NDC 68083-614

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-614Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0614Add 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
68083-614-01	6808306140168083061401	1 VIAL in 1 CARTON (68083-614-01) / 18 mL in 1 VIALMarketed from Oct 3, 2024

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): Chlorothiazide sodium
Generic name (nonproprietary): chlorothiazide sodium
Active ingredients: Chlorothiazide sodium — 500 mg/18mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218630
Marketing start: Oct 3, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 68083-614_e19fe503-9b2e-4db0-b4ee-0fb9ec9c11c2SPL ID e19fe503-9b2e-4db0-b4ee-0fb9ec9c11c2SPL set ID bf921935-9740-458e-b786-69f76d8ad139RxCUI 484152UNII SN86FG7N2KUPC 0368083614010
Pharmacologic class: Thiazide Diuretic

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

N468083061401 followed by a unit qualifier and the quantity

Package 68083-0614-01. 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 Oct 7, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Chlorothiazide sodium for injection is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorothiazide sodium for injection has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Use in Pregnancy Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during preg…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-614

What is NDC 68083-614?: 68083-614 is the product NDC for Chlorothiazide sodium, Chlorothiazide sodium 500 mg/18mL injection, powder, lyophilized, for solution, 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?: Chlorothiazide sodium.
What is the active ingredient?: Chlorothiazide 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 Chlorothiazide sodium?: 3 other product NDCs are listed under this name. See all Chlorothiazide 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 Chlorothiazide sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
chlorothiazide sodium	Chlorothiazide sodium 500 mg/18mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sagent Pharmaceuticals	25021-305	25021-0305-66
Chlorothiazide Sodium	Chlorothiazide sodium 500 mg/18mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sun Pharmaceutical Industries, Inc.	47335-330	47335-0330-40
Chlorothiazide Sodium	Chlorothiazide sodium 500 mg/18mL	Injection, Powder, Lyophilized, For solutionIntravenous	American Regent, Inc.	0517-1820	00517-1820-01