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Roflumilast - Medication Information

Product NDC Code 70771-1673
Drug Name

Roflumilast

Type Generic
Pharm Class Phosphodiesterase 4 Inhibitor [EPC],
Phosphodiesterase 4 Inhibitors [MoA]
Active Ingredients
Roflumilast 250 ug/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 1091839,
2001319
Application Number ANDA208303
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
70771-1673-3 2 blister pack in 1 carton (70771-1673-3) / 10 tablet in 1 blister pack (70771-1673-2)
70771-1673-8 1 blister pack in 1 carton (70771-1673-8) / 28 tablet in 1 blister pack
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Spl product data elements

Usually a list of ingredients in a drug product.
Roflumilast Roflumilast ROFLUMILAST ROFLUMILAST CELLULOSE, MICROCRYSTALLINE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLOXAMER 407 SILICON DIOXIDE STARCH, CORN off-white T5 Roflumilast Roflumilast ROFLUMILAST ROFLUMILAST CELLULOSE, MICROCRYSTALLINE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLOXAMER 407 SILICON DIOXIDE STARCH, CORN off-white T6

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1674-3 Roflumilast Tablets, 500 mcg 30 tablets Rx only NDC 70771-1673-8 Roflumilast Tablets, 250 mcg Blister pack of 28 tablets Rx only 500 mcg label 250 mcg blister label

Spl medguide

Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.
SPL MEDGUIDE

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API