Diphenhydramine NDC 63323-664

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-664Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0664Add 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
63323-664-16	63323066416	25 VIAL in 1 TRAY (63323-664-16) / 1 mL in 1 VIAL (63323-664-41)Marketed from Aug 1, 2002

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): Diphenhydramine
Generic name (nonproprietary): diphenhydramine hydrochloride
Active ingredients: Diphenhydramine hydrochloride — 50 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular, Intravenous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040466
Marketing start: Aug 1, 2002
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 63323-664_38e8f892-3aa1-473f-9906-8b7ee5d23e89SPL ID 38e8f892-3aa1-473f-9906-8b7ee5d23e89SPL set ID 921b9f64-1096-46db-866a-67f0f9ff6790RxCUI 1723740UNII TC2D6JAD40UPC 0363323664411
Pharmacologic class: Histamine-1 Receptor Antagonist

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

N463323066416 followed by a unit qualifier and the quantity

Package 63323-0664-16. 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 14, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Diphenhydramine hydrochloride in the injectable form is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when diphenhydramine hydrochloride in the oral form is impractical. Antihistaminic For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled, and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. Motion Sickness For active treatment of motion sickness. Antiparkinsonism For use in parkinsonism, when oral therapy is im…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040466

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

FDA NDC Directory listings under ANDA 040466
Product	Strength	Form · route	Labeler	Product NDC
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	Cardinal Health 107, LLC	55154-9363
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1348
Diphenhydraminediphenhydramine hydrochloride	Diphenhydramine hydrochloride 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	65219-820
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1374

Diphenhydramine (diphenhydramine hydrochloride) NDC 63323-664