Over-the-counter drug · OTC MONOGRAPH FINAL
Pseudo Time PE (Phenylephrine hchloride) NDC 49483-234
Phenylephrine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · TIME CAP LABORATORIES, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-234-00 | 49483023400 | 100000 TABLET, FILM COATED in 1 CARTON (49483-234-00)Marketed from Dec 14, 2018 | |
| 49483-234-18 | 49483023418 | 18 TABLET, FILM COATED in 1 BLISTER PACK (49483-234-18)Marketed from Dec 14, 2018 | |
| 49483-234-36 | 49483023436 | 36 TABLET, FILM COATED in 1 BLISTER PACK (49483-234-36)Marketed from Dec 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)
- Pseudo Time PE
- Generic name (nonproprietary)
- phenylephrine hchloride
- Active ingredients
- Phenylephrine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES, INC.NDC labeler code 49483
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (final)Application part341
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 49483-234_7d0279a6-3a55-e7e4-e053-2a91aa0a1df7SPL ID 7d0279a6-3a55-e7e4-e053-2a91aa0a1df7SPL set ID 3116f273-0517-4755-95cd-be3a7c0dd76bRxCUI 1049182UNII 04JA59TNSJUPC 9333728234183
- Pharmacologic class
- alpha-1 Adrenergic Agonist
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
N449483023400followed by a unit qualifier and the quantityPackage 49483-0234-00. 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 nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis Temporarily relieves sinus congestion and pressure
Excerpt only. Read the full label for complete information.
About NDC 49483-234
- What is NDC 49483-234?
- 49483-234 is the product NDC for Pseudo Time PE (phenylephrine hchloride), Phenylephrine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by TIME CAP LABORATORIES, INC.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pseudo Time PE (Phenylephrine hchloride).
- What is the active ingredient?
- Phenylephrine hydrochloride.
- Who is the labeler?
- TIME CAP LABORATORIES, 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 Pseudo Time PE?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
| Nightime Sleep Aiddiphenhydramine | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Velocity Pharma | 76168-065 |
| 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 |
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