What is NDC 76045-235?

76045-235 is the product NDC for Diphenhydramine Hydrochloride, Diphenhydramine hydrochloride 50 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 76045. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Diphenhydramine Hydrochloride?

81 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Diphenhydramine Hydrochloride NDC 76045-235

NDC codes

FDA NDC Directory

Product NDC (as listed)76045-235Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76045-0235Add 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
76045-235-10	76045023510	24 BLISTER PACK in 1 CARTON (76045-235-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-235-01) / 1 mL in 1 SYRINGE, GLASSMarketed from Jun 2, 2025

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 Hydrochloride
Generic name (nonproprietary): diphenhydramine hydrochloride
Active ingredients: Diphenhydramine hydrochloride — 50 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular, Intravenous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 76045
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091526
Marketing start: Jun 2, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 76045-235_5bfd2f08-2d90-47b1-9677-73c503e66956SPL ID 5bfd2f08-2d90-47b1-9677-73c503e66956SPL set ID 6d1aa0e2-036d-4382-a458-fc0300dba7cbRxCUI 1049289UNII TC2D6JAD40
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

N476045023510 followed by a unit qualifier and the quantity

Package 76045-0235-10. 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 Apr 3, 2025.

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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76045-235

What is NDC 76045-235?: 76045-235 is the product NDC for Diphenhydramine Hydrochloride, Diphenhydramine hydrochloride 50 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Diphenhydramine Hydrochloride.
What is the active ingredient?: Diphenhydramine hydrochloride.
Who is the labeler?: Fresenius Kabi USA, LLC, NDC labeler code 76045. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Diphenhydramine Hydrochloride?: 81 other product NDCs are listed under this name. See all Diphenhydramine 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 Diphenhydramine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 25 mg/1	TabletOral	Cardinal Health 107, LLC	55154-1589	55154-1589-00
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Health Pharma USA LLC	71679-308	71679-0308-00
Diphenhydramine hydrochloride	Diphenhydramine hydrochloride 12.5 mg/5mL	SolutionOral	Camber Pharmaceuticals, Inc.	31722-600	31722-0600-1131722-0600-31
Diphenhydramine hydrochloride	Diphenhydramine hydrochloride 25 mg/10mL	SolutionOral	Camber Pharmaceuticals, Inc.	31722-601	31722-0601-31
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 50 mg/mL	InjectionIntramuscular, Intravenous	REMEDYREPACK INC.	70518-4536	70518-4536-00
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 50 mg/mL	InjectionIntramuscular, Intravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-263	23155-0263-31
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 50 mg/mL	InjectionIntramuscular, Intravenous	Micro Labs Limited	42571-511	42571-0511-56
Diphenhydramine hydrochloride	Diphenhydramine hydrochloride 50 mg/mL	InjectionIntramuscular, Intravenous	REMEDYREPACK INC.	70518-4455	70518-4455-00
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 50 mg/1	Capsule, Liquid filledOral	Prodose, Inc.	68210-5057	68210-5057-01
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 50 mg/mL	InjectionIntramuscular, Intravenous	Medical Purchasing Solutions, LLC	71872-7373	71872-7373-01

All 82 Diphenhydramine Hydrochloride NDCs

Other NDCs under ANDA 091526

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

FDA NDC Directory listings under ANDA 091526
Product	Strength	Form · route	Labeler	Product NDC
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	76045-102