What is NDC 68083-365?

68083-365 is the product NDC for Rocuronium Bromide, Rocuronium bromide 10 mg/mL 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 Rocuronium Bromide?

53 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Rocuronium Bromide NDC 68083-365 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-365Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0365Add 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
68083-365-10	6808303651068083036510	10 VIAL, MULTI-DOSE in 1 CARTON (68083-365-10) / 10 mL in 1 VIAL, MULTI-DOSE (68083-365-01)Marketed from May 18, 2018

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): Rocuronium Bromide
Generic name (nonproprietary): rocuronium bromide
Active ingredients: Rocuronium bromide — 10 mg/mL
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 205656
Marketing start: May 18, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Neuromuscular Nondepolarizing Blockade (Physiologic effect)
Identifiers: Product ID 68083-365_f0786673-741a-4016-9528-268128b3b142SPL ID f0786673-741a-4016-9528-268128b3b142SPL set ID a223a740-dbe8-4d06-8b8b-d9104b694e62RxCUI 1234995UNII I65MW4OFHZUPC 0368083365011
Pharmacologic class: Nondepolarizing Neuromuscular Blocker

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

N468083036510 followed by a unit qualifier and the quantity

Package 68083-0365-10. 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 Jan 8, 2025.

Indications (excerpt from the label)

Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-365

What is NDC 68083-365?: 68083-365 is the product NDC for Rocuronium Bromide, Rocuronium bromide 10 mg/mL 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?: Rocuronium Bromide.
What is the active ingredient?: Rocuronium bromide.
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 Rocuronium Bromide?: 53 other product NDCs are listed under this name. See all Rocuronium Bromide 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 Rocuronium Bromide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Rocuronium Bromide	Rocuronium bromide 50 mg/5mL	Injection, SolutionIntravenous	Baxter Healthcare Corporation	43066-507	43066-0507-05
Rocuronium Bromide	Rocuronium bromide 100 mg/10mL	Injection, SolutionIntravenous	Baxter Healthcare Corporation	43066-509	43066-0509-05
Rocuronium Bromide	Rocuronium bromide 50 mg/5mL	InjectionIntravenous	B. Braun Medical Inc.	0264-5711	00264-5711-10
Rocuronium Bromide	Rocuronium bromide 50 mg/5mL	InjectionIntravenous	Lifestar Pharma LLC	70756-669	70756-0669-1070756-0669-85
Rocuronium Bromide	Rocuronium bromide 100 mg/10mL	InjectionIntravenous	Lifestar Pharma LLC	70756-670	70756-0670-1070756-0670-86
Rocuronium Bromide	Rocuronium bromide 50 mg/5mL	Injection, SolutionIntravenous	STERISCIENCE SPECIALTIES PRIVATE LIMITED	82449-001	82449-0001-02
Rocuronium Bromide	Rocuronium bromide 10 mg/mL	Injection, SolutionIntravenous	Caplin Steriles Limited	65145-130	65145-0130-10
Rocuronium Bromide	Rocuronium bromide 10 mg/mL	Injection, SolutionIntravenous	Caplin Steriles Limited	65145-131	65145-0131-10
Rocuronium Bromide	Rocuronium bromide 10 mg/mL	Injection, SolutionIntravenous	Medical Purchasing Solutions, LLC	71872-7372	71872-7372-01
Rocuronium Bromide	Rocuronium bromide 10 mg/mL	Injection, SolutionIntravenous	ProPharma Distribution	84549-131	84549-0131-10

All 54 Rocuronium Bromide NDCs

Other NDCs under ANDA 205656

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

FDA NDC Directory listings under ANDA 205656
Product	Strength	Form · route	Labeler	Product NDC
rocuronium bromide	Rocuronium bromide 10 mg/mL	Injection, SolutionIntravenous	Hospira, Inc.	0409-1403
rocuronium bromide	Rocuronium bromide 10 mg/mL	Injection, SolutionIntravenous	Hospira, Inc.	0409-3189
rocuronium bromide	Rocuronium bromide 10 mg/mL	Injection, SolutionIntravenous	Hospira, Inc.	0409-5160
rocuronium bromide	Rocuronium bromide 10 mg/mL	Injection, SolutionIntravenous	Hospira, Inc.	0409-7037
Rocuronium Bromide	Rocuronium bromide 10 mg/mL	InjectionIntravenous	Sagent Pharmaceuticals	25021-687
Rocuronium Bromide	Rocuronium bromide 10 mg/mL	Injection, SolutionIntravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1640
Rocuronium Bromide	Rocuronium bromide 10 mg/mL	Injection, SolutionIntravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1641
Rocuronium Bromide	Rocuronium bromide 10 mg/mL	InjectionIntravenous	Gland Pharma Limited	68083-364
Rocuronium Bromide	Rocuronium bromide 10 mg/mL	InjectionIntravenous	ProPharma Distribution	84549-687