NDC 71403-101 Minolira Extended Release

Minocycline Hydrochloride

NDC Product Code 71403-101

NDC Code: 71403-101

Proprietary Name: Minolira Extended Release Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Minocycline Hydrochloride Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Product Characteristics
Color(s):
WHITE (C48325)
Shape: RECTANGLE (C48347)
Size(s):
20 MM
19 MM
Imprint(s):
M3
M1
Score: 2

Code Structure
  • 71403 - Epi Health, Inc
    • 71403-101 - Minolira Extended Release

NDC 71403-101-05

Package Description: 1 BOTTLE in 1 CARTON > 5 TABLET in 1 BOTTLE

NDC 71403-101-30

Package Description: 1 BOTTLE in 1 CARTON > 30 TABLET in 1 BOTTLE

NDC Product Information

Minolira Extended Release with NDC 71403-101 is a a human prescription drug product labeled by Epi Health, Inc. The generic name of Minolira Extended Release is minocycline hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Epi Health, Inc

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Prescription Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Minolira Extended Release Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MINOCYCLINE HYDROCHLORIDE 105 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
  • TALC (UNII: 7SEV7J4R1U)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)
  • HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
  • WATER (UNII: 059QF0KO0R)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
  • TALC (UNII: 7SEV7J4R1U)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)
  • HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

Additional informationCallout TooltipWhat is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Tetracycline-class Drug - [EPC] (Established Pharmacologic Class)
  • Tetracyclines - [CS]

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Epi Health, Inc
Labeler Code: 71403
FDA Application Number: NDA209269 Additional informationCallout TooltipWhat is the FDA Application Number?
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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 03-15-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Minocycline

Minocycline is pronounced as (mi noe sye' kleen)

Why is minocycline medication prescribed?
Minocycline is used to treat infections caused by bacteria including pneumonia and other respiratory tract infections; certain infections of the skin, eye, lymphatic, in...
[Read More]

* Please review the disclaimer below.

Minolira Extended Release Product Label Images