NDC 71403-102

Minolira Extended Release

Minocycline Hydrochloride

Minolira Extended Release is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Epi Health, Inc. The primary component is Minocycline Hydrochloride.

Product ID71403-102_3baf89cd-eb0d-465e-baa9-2f5539d3fad9
NDC71403-102
Product TypeHuman Prescription Drug
Proprietary NameMinolira Extended Release
Generic NameMinocycline Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-03-15
Marketing CategoryNDA / NDA
Application NumberNDA209269
Labeler NameEPI Health, Inc
Substance NameMINOCYCLINE HYDROCHLORIDE
Active Ingredient Strength135 mg/1
Pharm ClassesTetracycline-class Drug [EPC],Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71403-102-05

1 BOTTLE in 1 CARTON (71403-102-05) > 5 TABLET in 1 BOTTLE
Marketing Start Date2019-03-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71403-102-30 [71403010230]

Minolira Extended Release TABLET
Marketing CategoryNDA
Application NumberNDA209269
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-15

NDC 71403-102-05 [71403010205]

Minolira Extended Release TABLET
Marketing CategoryNDA
Application NumberNDA209269
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-15

Drug Details

Active Ingredients

IngredientStrength
MINOCYCLINE HYDROCHLORIDE135 mg/1

OpenFDA Data

SPL SET ID:523856a4-530b-4a23-a80a-d72ab08e2c08
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 629695
  • 2058529
  • 1013659
  • 1941489
    • UPC Code
  • 0371403101053
  • 0371403102302

    • Pharmacological Class

    • Tetracycline-class Drug [EPC]
    • Tetracyclines [CS]

    NDC Crossover Matching brand name "Minolira Extended Release" or generic name "Minocycline Hydrochloride"

    NDCBrand NameGeneric Name
    71403-101Minolira Extended ReleaseMinolira Extended Release
    71403-102Minolira Extended ReleaseMinolira Extended Release
    0093-2133Minocycline HydrochlorideMinocycline Hydrochloride
    0093-2134Minocycline HydrochlorideMinocycline Hydrochloride
    0093-7741Minocycline HydrochlorideMinocycline Hydrochloride
    0093-7742Minocycline HydrochlorideMinocycline Hydrochloride
    0093-7743Minocycline HydrochlorideMinocycline Hydrochloride
    0115-9935minocycline hydrochlorideminocycline hydrochloride
    0115-9936minocycline hydrochlorideminocycline hydrochloride
    0378-4293Minocycline Hydrochlorideminocycline hydrochloride
    0378-4294Minocycline Hydrochlorideminocycline hydrochloride
    0440-7805Minocycline hydrochlorideMinocycline hydrochloride
    0591-3153Minocycline HydrochlorideMinocycline Hydrochloride
    0591-5694Minocycline HydrochlorideMinocycline Hydrochloride
    0591-5695Minocycline HydrochlorideMinocycline Hydrochloride
    0781-5385Minocycline HydrochlorideMinocycline Hydrochloride
    0781-5386Minocycline HydrochlorideMinocycline Hydrochloride
    0781-5387Minocycline HydrochlorideMinocycline Hydrochloride
    0904-6888Minocycline HydrochlorideMinocycline Hydrochloride
    13668-482Minocycline HydrochlorideMinocycline Hydrochloride
    10631-330Ximinominocycline hydrochloride
    10631-331Ximinominocycline hydrochloride
    10631-332Ximinominocycline hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.