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 DirectoryProduct NDC (as listed)49483-329Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49483-0329Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-329-00 | 4948303290049483032900 | 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, IncNDC labeler code 49483
- 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses: Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies; runny nose, itchy watery eyes; sneezing; itchy nose or throat Temporarily relieves these symptoms due to the common cold: runny nose; sneezing
Excerpt only. Read the full label for complete information.
About NDC 49483-329
- What is NDC 49483-329?
- 49483-329 is the product NDC for Diphenhydramine Hydrochloride, Diphenhydramine hydrochloride 25 mg/1 tablet, coated, listed with the FDA by Time-Cap Labs, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diphenhydramine Hydrochloride.
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Time-Cap Labs, Inc, NDC labeler code 49483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diphenhydramine Hydrochloride?
- 80 other product NDCs are listed under this name. See all Diphenhydramine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diphenhydramine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-1589 | 55154-1589-00 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Health Pharma USA LLC | 71679-308 | 71679-0308-00 |
| Diphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-600 | 31722-0600-1131722-0600-31 |
| Diphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/10mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-601 | 31722-0601-31 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-4536 | 70518-4536-00 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-263 | 23155-0263-31 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Micro Labs Limited | 42571-511 | 42571-0511-56 |
| Diphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-4455 | 70518-4455-00 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Prodose, Inc. | 68210-5057 | 68210-5057-01 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7373 | 71872-7373-01 |
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 |
|---|---|---|---|---|
| Pseudo Time PEphenylephrine hchloride | Phenylephrine hydrochloride 10 mg/1 | Tablet, Film coatedOral | TIME CAP LABORATORIES, INC. | 49483-234 |
| Allergy Timechlorpheniramine maleate | Chlorpheniramine maleate 4 mg/1 | TabletOral | Time Cap Labs Inc | 49483-242 |
| CVS Health Sinus Reliefoxymetazoline hydrochloride | Oxymetazoline hydrochloride .0005 g/mL | SprayNasal | CVS Pharmacy,Inc. | 59779-787 |
| Severe Cold Head Congestionacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Marc Glassman, Inc. | 68998-175 |
| CVS Health Childrens Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | CVS Pharmacy,Inc. | 59779-793 |
| CVS Health Four Actions Nasal Decongestantphenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | SprayNasal | CVS Pharmacy,Inc. | 59779-838 |
| Tussin CFdextromethorphan hbr guaifenesin phenylephrine hcl | Dextromethorphan hydrobromide 20 mg/10mL + 2 more ingredients | SolutionOral | Strategic Sourcing Services | 70677-1187 |
| Tussinguaifenesin | Guaifenesin 200 mg/10mL | SolutionOral | Strategic Sourcing Services | 70677-1186 |
| Discount Drug Mart Value Vapor Steamcamphor (synthetic) | Camphor (Synthetic) .623 g/10mL | LiquidRespiratory (Inhalation) | Drug Mart | 53943-256 |
| Pressure Pain Mucus PEacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Chain Drug Marketing Association | 63868-747 |
| 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 |
| Nightime Sleep Aiddiphenhydramine | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Velocity Pharma | 76168-065 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-648 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-649 |
| Pi Yuan Chinnaphazoline hydrochloride | Naphazoline hydrochloride 1 mg/1 | Solution/ dropsNasal | International Nature Nutraceuticals | 51367-035 |
| Sugar Free Cherry Cough Dropsmenthol | Menthol 5.8 1/1 | LozengeOral | Army & Air Force Exchange Service | 55301-038 |
| 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 |
| Best Choice Effervescent Cold Reliefaspirin, chlorpheniramine maleate, phenylephrine bitartrate | Aspirin 325 mg/1 + 2 more ingredients | Tablet, EffervescentOral | Valu Merchandiser Company | 63941-873 |
| CVS Health Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | CVS Pharmacy,Inc. | 69842-753 |
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