Over-the-counter drug · OTC MONOGRAPH FINAL
Sleep Aid (Diphenhydramine hydrochloride) NDC 76168-015
Diphenhydramine hydrochloride 25 mg/1 · Tablet, Film coated · Oral · Velocity Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76168-015-07 | 7616800150776168001507 | 1 BOTTLE in 1 CARTON (76168-015-07) / 36 TABLET, FILM COATED in 1 BOTTLEMarketed from May 14, 2018 | |
| 76168-015-12 | 7616800151276168001512 | 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 LLCNDC labeler code 76168
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (final)Application part338
- Marketing start
- Listing expires
- 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
N476168001507followed by a unit qualifier and the quantityPackage 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 .
Indications (excerpt from the label)
Use for relief of occasional sleeplessness
Excerpt only. Read the full label for complete information.
About NDC 76168-015
- What is NDC 76168-015?
- 76168-015 is the product NDC for Sleep Aid (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Velocity Pharma LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sleep Aid (Diphenhydramine hydrochloride).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Velocity Pharma LLC, NDC labeler code 76168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sleep Aid?
- 58 other product NDCs are listed under this name. See all Sleep Aid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sleep Aid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Amazon.com Services LLC | 72288-432 | 72288-0432-01 |
| Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Shield Pharmaceuticals Corp | 83059-0075 | 83059-0075-08 |
| Sleep Aidaconitum napellus, aesculus hippocastanum, flos, arsenicum album, avena sativa, belladonna, camphora, cinchona officinalis, coffea cruda, cypripedium pubescens, hyoscyamus niger, ignatia amara, kali phosphoricum, passiflora incarnata, phosphorus, pulsatilla, and valeriana officinalis. | Aconitum napellus whole 10 [hp_X]/59mL + 15 more ingredients | LiquidOral | King Bio Inc. | 57955-9986 | 57955-9986-02 |
| Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Chewable gelOral | Walgreens | 0363-9236 | 00363-9236-50 |
| Sleep-Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Chewable gelOral | WALMART INC. (see also Equate) | 79903-426 | 79903-0426-24 |
| Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | TARGET Corporation | 82442-530 | 82442-0530-3282442-0530-60 |
| Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | WALGREENS | 0363-6130 | 00363-6130-2400363-6130-48 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-368 | 51316-0368-22 |
| sleep aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Publix Super Markets Inc | 56062-441 | 56062-0441-01 |
| sleep aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Walgreen Company | 0363-3462 | 00363-3462-80 |
Other NDCs under part338
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nighttime Sleep-Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | Guardian Drug Company | 53041-633 |
| Nighttime Sleep-Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | Chain Drug Marketing Association Inc. | 83324-015 |