What is NDC 68083-586?

68083-586 is the product NDC for isoproterenol hydrochloride, Isoproterenol hydrochloride 1 mg/5mL injection, 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 isoproterenol hydrochloride?

19 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

isoproterenol hydrochloride NDC 68083-586

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-586Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0586Add 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
68083-586-10	6808305861068083058610	10 VIAL in 1 CARTON (68083-586-10) / 5 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): isoproterenol hydrochloride
Generic name (nonproprietary): isoproterenol hydrochloride
Active ingredients: Isoproterenol hydrochloride — 1 mg/5mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217648
Marketing start: Oct 3, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta-Agonists (Mechanism)
Identifiers: Product ID 68083-586_a5d2e484-b959-4eef-9988-290ea1668c61SPL ID a5d2e484-b959-4eef-9988-290ea1668c61SPL set ID 2581854e-e654-4ac3-98e8-36c9f27748bfRxCUI 1667909, 1667915UNII DIA2A74855
Pharmacologic class: beta-Adrenergic Agonist

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

N468083058610 followed by a unit qualifier and the quantity

Package 68083-0586-10. 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 Oct 7, 2024.

Indications (excerpt from the label)

Isoproterenol hydrochloride injection is indicated: • To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output • For bronchospasm occurring during anesthesia Isoproterenol hydrochloride injection is a beta-adrenergic agonist indicated: • To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output ( 1 ) • For treatment of bronchospasm occurring during anesthesia ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-586

What is NDC 68083-586?: 68083-586 is the product NDC for isoproterenol hydrochloride, Isoproterenol hydrochloride 1 mg/5mL injection, 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?: isoproterenol hydrochloride.
What is the active ingredient?: Isoproterenol hydrochloride.
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 isoproterenol hydrochloride?: 19 other product NDCs are listed under this name. See all isoproterenol hydrochloride 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 isoproterenol hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Isoproterenol Hydrochloride	Isoproterenol hydrochloride .2 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-324	25021-0324-0125021-0324-05
isoproterenol hydrochloride	Isoproterenol hydrochloride .2 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-585	68083-0585-25
Isoproterenol Hydrochloride	Isoproterenol hydrochloride .2 mg/mL	Injection, SolutionIntracardiac, Intramuscular, Intravenous, Subcutaneous	Nordic Pharma, Inc.	69918-731	69918-0731-11
Isoproterenol Hydrochloride	Isoproterenol hydrochloride .2 mg/mL	Injection, SolutionIntravenous	Avenacy, Inc.	83634-303	83634-0303-0183634-0303-05
Isoproterenol hydrochloride	Isoproterenol hydrochloride .2 mg/mL	Injection, SolutionIntravenous	KVK-Tech, Inc.	10702-364	10702-0364-51
Isoproterenol Hydrochloride	Isoproterenol hydrochloride .2 mg/mL	Injection, SolutionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-660	23155-0660-4123155-0660-4223155-0660-43
Isoproterenol Hydrochloride	Isoproterenol hydrochloride .2 mg/mL	Injection, SolutionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-661	23155-0661-4123155-0661-42
Isoproterenol Hydrochloride	Isoproterenol hydrochloride .2 mg/mL	InjectionIntracardiac, Intramuscular, Intravenous, Subcutaneous	Armas Pharmaceuticals Inc.	72485-113	72485-0113-10
Isoproterenol Hydrochloride	Isoproterenol hydrochloride .2 mg/mL	Injection, SolutionIntracardiac, Intramuscular, Intravenous, Subcutaneous	Nordic Pharma, Inc.	69918-735	69918-0735-10
Isoproterenol Hydrochloride	Isoproterenol hydrochloride .2 mg/mL	InjectionIntravenous	Micro Labs Limited	42571-294	42571-0294-79

All 20 isoproterenol hydrochloride NDCs

Other NDCs under ANDA 217648

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

FDA NDC Directory listings under ANDA 217648
Product	Strength	Form · route	Labeler	Product NDC
Isoproterenol Hydrochloride	Isoproterenol hydrochloride .2 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-324
isoproterenol hydrochloride	Isoproterenol hydrochloride .2 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-585