Sleep Aid (diphenhydramine hydrochloride) NDC 76168-015

NDC codes

FDA NDC Directory

Product NDC (as listed)76168-015Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76168-0015Add 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
76168-015-07	76168001507	1 BOTTLE in 1 CARTON (76168-015-07) / 36 TABLET, FILM COATED in 1 BOTTLEMarketed from May 14, 2018
76168-015-12	76168001512	1 BOTTLE in 1 CARTON (76168-015-12) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from May 14, 2018

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): Sleep Aid
Generic name (nonproprietary): diphenhydramine hydrochloride
Active ingredients: Diphenhydramine hydrochloride — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Velocity Pharma LLC
Product type: Over-the-counter drug
Marketing category: OTC monograph (final)Application part338
Marketing start: May 14, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 76168-015_6c311047-4bf2-44ad-e053-2a91aa0ad047SPL ID 6c311047-4bf2-44ad-e053-2a91aa0ad047SPL set ID 035454a1-d23b-4faf-8fac-a59fc77ce18cRxCUI 1049630UNII 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

N476168001507 followed by a unit qualifier and the quantity

Package 76168-0015-07. 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 May 14, 2018.

Indications (excerpt from the label)

Use for relief of occasional sleeplessness

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under part338

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

FDA NDC Directory listings under part338
Product	Strength	Form · route	Labeler	Product NDC
Nighttime Sleep-Aiddiphenhydramine hcl	Diphenhydramine hydrochloride 50 mg/30mL	LiquidOral	Chain Drug Marketing Association Inc.	83324-015
Nighttime Sleep-Aiddiphenhydramine hcl	Diphenhydramine hydrochloride 50 mg/30mL	LiquidOral	Guardian Drug Company	53041-633