Diphenhydramine Hydrochloride NDC 0121-0489

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-0489Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-0489Add 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
0121-0489-00	00121048900	10 TRAY in 1 CASE (0121-0489-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0489-05)Marketed from Feb 10, 1982

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 12.5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: PAI Holdings, LLC dba PAI Pharma
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 087513
Marketing start: Feb 10, 1982
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0121-0489_b7eb09fa-58fb-4c3f-ad65-a04965bc52b0SPL ID b7eb09fa-58fb-4c3f-ad65-a04965bc52b0SPL set ID 6fe6fe2d-4405-4e7a-a2ed-5eb367d52842RxCUI 1049906UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400121048900 followed by a unit qualifier and the quantity

Package 00121-0489-00. 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 5, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Diphenhydramine hydrochloride in the oral form is effective for the following indications: Antihistaminic For allergic conjunctivitis due to foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; amelioration of allergic reactions to blood or plasma; dermatographism; as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. Motion Sickness For active and prophylactic treatment of motion sickness. Antiparkinsonism For parkinsonism (including drug-induced) in the elderly unable to tolerate more potent agents; mild cases of parkinsonism (including drug-induc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 087513

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

FDA NDC Directory listings under ANDA 087513
Product	Strength	Form · route	Labeler	Product NDC
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 25 mg/10mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-0978
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 25 mg/10mL	SolutionOral	Medical Purchasing Solutions, LLC	71872-7242
Diphenhydramine HCLdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 12.5 mg/5mL	SolutionOral	Redmont Pharmaceuticals, LLC	71741-511