What is NDC 68083-611?

68083-611 is the product NDC for Diphenhydramine Hydrochloride, Diphenhydramine hydrochloride 50 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 Diphenhydramine Hydrochloride?

78 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 68083-611

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-611Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0611Add 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
68083-611-25	68083061125	25 VIAL in 1 CARTON (68083-611-25) / 1 mL in 1 VIALMarketed from Mar 20, 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): Diphenhydramine Hydrochloride
Generic name (nonproprietary): diphenhydramine hydrochloride
Active ingredients: Diphenhydramine hydrochloride — 50 mg/mL
Dosage form: Injection
Route: Intramuscular, Intravenous
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218448
Marketing start: Mar 20, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 68083-611_89f09a33-2535-47c9-8942-dd8ebe5d3b4aSPL ID 89f09a33-2535-47c9-8942-dd8ebe5d3b4aSPL set ID eeb70724-065c-4a73-8e2e-d6b2a625e8d4RxCUI 1723740UNII 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

N468083061125 followed by a unit qualifier and the quantity

Package 68083-0611-25. 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 Mar 22, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Diphenhydramine Hydrochloride Injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when 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 impossible or contraindicated, as follows: parkins…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-611

What is NDC 68083-611?: 68083-611 is the product NDC for Diphenhydramine Hydrochloride, Diphenhydramine hydrochloride 50 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?: Diphenhydramine Hydrochloride.
What is the active ingredient?: Diphenhydramine 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 Diphenhydramine Hydrochloride?: 78 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	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-264	23155-0264-41

All 79 Diphenhydramine Hydrochloride NDCs

Other NDCs under ANDA 218448

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

FDA NDC Directory listings under ANDA 218448
Product	Strength	Form · route	Labeler	Product NDC
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-481