Diurex
Pamabrom
Alva-amco Pharmacal Companies, Inc.
Human Otc Drug
NDC 52389-325Diurex also known as Pamabrom is a human otc drug labeled by 'Alva-amco Pharmacal Companies, Inc.'. National Drug Code (NDC) number for Diurex is 52389-325. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Diurex drug includes Pamabrom - 50 mg/1 . The currest status of Diurex drug is Active.
Drug Information:
| Drug NDC: | 52389-325 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Diurex |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Pamabrom |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Alva-amco Pharmacal Companies, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | PAMABROM - 50 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Apr, 2005 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | M027 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Alva-Amco Pharmacal Companies, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 832080
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0072959255213
|
| UPC stands for Universal Product Code. |
| UNII: | UA8U0KJM72
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 52389-325-21 | 1 BLISTER PACK in 1 CARTON (52389-325-21) / 21 CAPSULE in 1 BLISTER PACK (52389-325-01) | 01 Apr, 2005 | N/A | No |
| 52389-325-42 | 2 BLISTER PACK in 1 CARTON (52389-325-42) / 21 CAPSULE in 1 BLISTER PACK (52389-325-01) | 01 Oct, 2006 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose diuretic
Product Elements:
Diurex pamabrom anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 gelatin magnesium oxide polysorbate 80 potassium sorbate povidone propylene glycol riboflavin shellac sodium hydroxide sucrose butyl alcohol titanium dioxide starch, corn pamabrom bromotheophylline clear, colorless capsule containing blue, white and golden beads, sealed closed with a blue band. clear number 1 capsule alva
Indications and Usage:
Uses for the relief of temporary water weight gain bloating swelling full feeling associated with the premenstrual and menstrual periods
Warnings:
Warnings
Dosage and Administration:
Directions read all package directions and warnings before use. use only as directed. adults: take one (1) capsule after breakfast with a full glass of water. dose may be repeated after six (6) hours, not to exceed four (4) capsules per day. start taking 5 or 6 days before onset of period and continue until desired relief is obtained or end of period. drink 6 to 8 glasses of water daily. for use by normally healthy adults only. persons under 18 years of age should use only as directed by a doctor. note: the appearance of golden-tinted urine, which may occur after taking diurex water capsules, is a normal and temporary effect.
Stop Use:
Stop use and ask a doctor if symptoms last for more than ten consecutive days.
Information for Patients:
Other information **contents sealed: each diurex capsule bears the identifying mark "alva" in red, contains white, blue and golden colored beads and is sealed closed with a blue band, then further sealed in a clear plastic blister with a foil backing. do not use if seal appears broken or if contents do not match product description. you may report serious side effects to the phone number provided under questions? below.
Package Label Principal Display Panel:
Diurexcapsulespdp
Further Questions:
Questions? 1-800-792-2582