NDC 43598-539

Minolira

Minolira

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

• Product ID: 43598-539_7c7a3d89-29a7-e845-a140-b4d1e4139ebb
• NDC: 43598-539
• Product Type: Human Prescription Drug
• Proprietary Name: Minolira
• Generic Name: Minolira
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2017-08-08
• Marketing Category: NDA / NDA
• Application Number: NDA209269
• Labeler Name: Dr. Reddys Laboratories Inc
• Substance Name: MINOCYCLINE HYDROCHLORIDE
• Active Ingredient Strength: 135 mg/1
• Pharm Classes: Tetracycline-class Drug [EPC],Tetracyclines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 43598-539-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-539-30)

• Marketing Start Date: 2017-08-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43598-539-30 [43598053930]

Minolira TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA209269
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-08-08
• Marketing End Date: 2019-04-22

Drug Details

Active Ingredients

Ingredient	Strength
MINOCYCLINE HYDROCHLORIDE	135 mg/1

OpenFDA Data

• SPL SET ID: f732096d-9e6d-2026-59f1-ee0dd412bb4d
• Manufacturer:
  • Dr. Reddys Laboratories Inc
• UNII:
  • 0020414E5U
• RxNorm Concept Unique ID - RxCUI:
  • 629695
  • 1013659
• UPC Code:
  • 0343598540306
  • 0343598539300

Pharmacological Class

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

NDC Crossover Matching brand name "Minolira" or generic name "Minolira"

NDC	Brand Name	Generic Name
43598-539	Minolira	Minolira
43598-540	Minolira	Minolira