Search by Drug Name or NDC
NDC 51660-0204-21 Pseudoephedrine hydrochloride 120 mg/1 Details
Pseudoephedrine hydrochloride 120 mg/1
Pseudoephedrine hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Ohm Laboratories Inc.. The primary component is PSEUDOEPHEDRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
Related Packages: 51660-0204-21Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 51660-0204 |
|---|---|
| Product ID | 51660-204_11bd16c8-f5e0-4dac-9667-f4ed02c6aee5 |
| Associated GPIs | 42101020107405 |
| GCN Sequence Number | 016937 |
| GCN Sequence Number Description | pseudoephedrine HCl TABLET ER 120 MG ORAL |
| HIC3 | B6V |
| HIC3 Description | DECONGESTANTS, ORAL |
| GCN | 26901 |
| HICL Sequence Number | 002091 |
| HICL Sequence Number Description | PSEUDOEPHEDRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Pseudoephedrine hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Pseudoephedrine hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 120 |
| Active Ingredient Units | mg/1 |
| Substance Name | PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Ohm Laboratories Inc. |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077442 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 51660-0204-21 (51660020421)
| NDC Package Code | 51660-204-21 |
|---|---|
| Billing NDC | 51660020421 |
| Package | 20 TABLET, FILM COATED in 1 BLISTER PACK (51660-204-21) |
| Marketing Start Date | 2006-04-28 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.27385 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | PSEUDOEPHEDRINE ER 120 MG TAB |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL 4e98dd9f-4ab9-4d95-95b0-799ce217da70 Details
Uses
Warnings
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
Directions
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton
INGREDIENTS AND APPEARANCE
| PSEUDOEPHEDRINE HYDROCHLORIDE
pseudoephedrine hydrochloride tablet, film coated |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
| Labeler - Ohm Laboratories Inc. (184769029) |
| Registrant - Ohm Laboratories Inc. (184769029) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Ohm Laboratories Inc. | 051565745 | manufacture(51660-204) | |
Revised: 3/2019
Document Id: 11bd16c8-f5e0-4dac-9667-f4ed02c6aee5
Set id: 4e98dd9f-4ab9-4d95-95b0-799ce217da70
Version: 2
Effective Time: 20190313