Over-the-counter drug · OTC MONOGRAPH FINAL
Diphenhydramine Hydrochloride NDC 49483-329
Diphenhydramine hydrochloride 25 mg/1 · Tablet, Coated · Oral · Time-Cap Labs, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-329-00 | 49483032900 | 100000 TABLET, COATED in 1 CARTON (49483-329-00)Marketed from Dec 17, 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)
- Diphenhydramine Hydrochloride
- Generic name (nonproprietary)
- diphenhydramine hydrochloride
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Time-Cap Labs, Inc
- 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 49483-329_7d3b9a35-9e04-4289-e053-2a91aa0a5042SPL ID 7d3b9a35-9e04-4289-e053-2a91aa0a5042SPL set ID ed899055-0cbb-45bd-92c8-cbef2fc7c361RxCUI 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
N449483032900followed by a unit qualifier and the quantityPackage 49483-0329-00. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 |
|---|---|---|---|---|
| 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 |
| Broncochem Maximum Coughdextromethorphan hbr-gyaifenesin | Dextromethorphan hydrobromide 30 mg/10mL; Guaifenesin 200 mg/10mL | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-091 |
| Best Choice Effervescent Cold Reliefaspirin, chlorpheniramine maleate, phenylephrine bitartrate | Aspirin 325 mg/1 + 2 more ingredients | Tablet, EffervescentOral | Valu Merchandiser Company | 63941-873 |
| Broncochem Kids Cold And Fluacetaminophen-phenylephrine hcl-guaifenesin | Acetaminophen 325 mg/10mL + 2 more ingredients | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-054 |
| CVS Health Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | CVS Pharmacy,Inc. | 69842-753 |
| Broncochem Allergy Controlcholpheniramine maleate-phenylephrine hcl | Chlorpheniramine maleate 4 mg/10mL; Phenylephrine hydrochloride 10 mg/10mL | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-098 |
| Effervescent Cold Reliefaspirin, chlorpheniramine maleate, phenylephrine bitartrate | Aspirin 325 mg/1 + 2 more ingredients | Tablet, EffervescentOral | Discount Drug Mart | 53943-873 |
| Childrens Multi-symptom Cold Daytimedextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients | LiquidOral | Wal-Mart Stores, Inc. | 79903-270 |
| Broncochem Kids Allergy Controlchlorpheniramine maleate-dextromethrophan hbr | Chlorpheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 10 mg/10mL | SyrupOral | LABORATORIO MAGANCEHM INTERNATIONAL SRL | 65131-418 |
| Childrens Mucus and Cough Reliefdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | Family Dollar Services, Inc. | 55319-924 |
| Anti Allergychlorpheniramine maleate | Chlorpheniramine maleate 4 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-103 |
| Mucus Reliefguaifenesin 200 mg | Guaifenesin 200 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-098 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-649 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Richmond Pharmaceuticals, Inc. | 54738-116 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-648 |
| Quality Choice Dye Free Cherry Childrens Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | Chain Drug Marketing Association Inc. | 83324-016 |
| Mucus Reliefguaifenesin 200 mg | Guaifenesin 200 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-980 |
| QCH Adult Tussin DM 542dextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 200 mg/20mL | LiquidOral | Chain Drug Marketing Association Inc. | 83324-023 |
| Mucus Reliefguaifenesin 400 mg | Guaifenesin 400 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-981 |
| QCH Adult Tussin 541guaifenesin | Guaifenesin 200 mg/10mL | LiquidOral | Chain Drug Marketing Association Inc. | 83324-024 |
Showing 20 of 40.