What is NDC 68083-465?

68083-465 is the product NDC for Phenylephrine Hydrochloride Phenylephrine Hydrochloride, Phenylephrine hydrochloride 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?

Phenylephrine Hydrochloride Phenylephrine Hydrochloride (Phenylephrine Hydrochloride).

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 Phenylephrine Hydrochloride Phenylephrine Hydrochloride?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

NDC 68083-465

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-465Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0465Add 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
68083-465-25	68083046525	25 VIAL in 1 CARTON (68083-465-25) / 1 mL in 1 VIAL (68083-465-01)Marketed from Apr 14, 2021

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): Phenylephrine Hydrochloride Phenylephrine HydrochlorideSuffix: Phenylephrine Hydrochloride
Generic name (nonproprietary): phenylephrine hydrochloride
Active ingredients: Phenylephrine hydrochloride — 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 211920
Marketing start: Apr 14, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)
Identifiers: Product ID 68083-465_61b63c37-7fc9-4557-acf6-eea73b84b4c3SPL ID 61b63c37-7fc9-4557-acf6-eea73b84b4c3SPL set ID 6486d284-5189-4000-aa7d-67150e84a7b2RxCUI 1232651, 1666372UNII 04JA59TNSJUPC 0368083338015, 0368083339012
Pharmacologic class: alpha-1 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

N468083046525 followed by a unit qualifier and the quantity

Package 68083-0465-25. 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 Apr 14, 2021.

Indications (excerpt from the label)

Phenylephrine hydrochloride injection, 10 mg/mL, is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine hydrochloride injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-465

What is NDC 68083-465?: 68083-465 is the product NDC for Phenylephrine Hydrochloride Phenylephrine Hydrochloride, Phenylephrine hydrochloride 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?: Phenylephrine Hydrochloride Phenylephrine Hydrochloride (Phenylephrine Hydrochloride).
What is the active ingredient?: Phenylephrine 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 Phenylephrine Hydrochloride Phenylephrine Hydrochloride?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 211920

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

FDA NDC Directory listings under ANDA 211920
Product	Strength	Form · route	Labeler	Product NDC
phenylephrine hydrochloride	Phenylephrine hydrochloride 10 mg/mL	InjectionIntravenous	Gland Pharma Limited	68083-338
phenylephrine hydrochloride	Phenylephrine hydrochloride 10 mg/mL	InjectionIntravenous	Gland Pharma Limited	68083-339

Phenylephrine Hydrochloride Phenylephrine Hydrochloride (Phenylephrine hydrochloride) NDC 68083-465