Over-the-counter drug · OTC MONOGRAPH FINAL
Nightime Sleep Aid (Diphenhydramine) NDC 76168-065
Diphenhydramine hydrochloride 50 mg/1 · Capsule, Liquid filled · Oral · Velocity Pharma
NDC codes
FDA NDC DirectoryProduct NDC (as listed)76168-065Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76168-0065Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76168-065-37 | 76168006537 | 16 CARTON in 1 BOTTLE (76168-065-37) / 1 CAPSULE, LIQUID FILLED in 1 CARTONMarketed from Mar 31, 2014 |
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)
- Nightime Sleep Aid
- Generic name (nonproprietary)
- diphenhydramine
- Active ingredients
- Diphenhydramine hydrochloride — 50 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Velocity PharmaNDC labeler code 76168
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (final)Application part341
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 76168-065_6cbc010f-0449-cb45-e053-2a91aa0a1ec6SPL ID 6cbc010f-0449-cb45-e053-2a91aa0a1ec6SPL set ID 9c44e54f-d8bc-4451-8382-40d2e8e03b42RxCUI 1020477UNII 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
N476168006537followed by a unit qualifier and the quantityPackage 76168-0065-37. 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)
Uses For relief of occasional sleeplessness.
Excerpt only. Read the full label for complete information.
About NDC 76168-065
- What is NDC 76168-065?
- 76168-065 is the product NDC for Nightime Sleep Aid (diphenhydramine), Diphenhydramine hydrochloride 50 mg/1 capsule, liquid filled, listed with the FDA by Velocity Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nightime Sleep Aid (Diphenhydramine).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Velocity Pharma, 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 Nightime Sleep Aid?
- 1 other product NDC are listed under this name. See all Nightime 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 Nightime 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) |
|---|---|---|---|---|---|
| Nightime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | BETTER LIVING BRANDS LLC. | 21130-711 | 21130-0711-0121130-0711-02 |
Other NDCs under part341
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 |
|---|---|---|---|---|
| QCH Adult Tussin DM Sugar free 545dextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 200 mg/20mL | LiquidOral | Chain Drug Marketing Association Inc. | 83324-025 |
| QCH Adult Tussin DM 542dextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 200 mg/20mL | LiquidOral | Chain Drug Marketing Association Inc. | 83324-023 |
| QCH Adult Tussin 541guaifenesin | Guaifenesin 200 mg/10mL | LiquidOral | Chain Drug Marketing Association Inc. | 83324-024 |
| Mucus Reliefguaifenesin 200 mg | Guaifenesin 200 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-980 |
| QCH Maximum Strength Mucus Relief DM 628dextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | LiquidOral | Chain Drug Marketing Association Inc. | 83324-026 |
| Mucus Reliefguaifenesin 400 mg | Guaifenesin 400 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-981 |
| Mucus Relief Cough and Congestion DMguaifenesin and dextromethorphan hbr | Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc | 54738-985 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-648 |
| Oxymethazoline HCL | Oxymetazoline hydrochloride .05 mg/1 | SprayNasal | Preferred Pharmaceuticals Inc. | 68788-7516 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-649 |
| robafen dmdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 200 mg/20mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8268 |
| Assured Vaporizing Chest Rubcamphor and eucalyptus oil and menthol | Camphor (Synthetic) 4.7 g/100g + 2 more ingredients | OintmentTopical | Greenbrier International, Inc. | 33992-7991 |
| Assured Vaporizing Chest Rubcamphor and eucalyptus oil and menthol | Camphor (Synthetic) 4.7 g/100g + 2 more ingredients | OintmentTopical | Greenbrier International, Inc. | 33992-7992 |
| Best Choice Vapor Steamcamphor (synthetic) | Camphor (Synthetic) .623 g/10mL | LiquidRespiratory (Inhalation) | Valu merchandiser | 63941-256 |
| NightTime Cold and Fluacetaminophen,dextromethorphan,doxylamine | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Velocity Pharma | 76168-056 |
| Allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Velocity Pharma LLC | 76168-121 |
| Tussinguaifenesin | Guaifenesin 200 mg/10mL | SolutionOral | Strategic Sourcing Services | 70677-1186 |
| Walgreens Adult Nighttime Wal Tussin DM Max Maximum Strengthdextromethorphan hbr, doxylamine succinate | Dextromethorphan hydrobromide 30 mg/20mL; Doxylamine succinate 12.5 mg/20mL | SolutionOral | WALGREEN CO. | 0363-0758 |
| Tussin CFdextromethorphan hbr guaifenesin phenylephrine hcl | Dextromethorphan hydrobromide 20 mg/10mL + 2 more ingredients | SolutionOral | Strategic Sourcing Services | 70677-1187 |
| Severe Cold Head Congestionacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Marc Glassman, Inc. | 68998-175 |
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