NDC 61748-303

Myorisan

Isotretinoin

Myorisan is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Versapharm, Inc. . The primary component is Isotretinoin.

• Product ID: 61748-303_0617329d-75f1-485d-8800-5b4fab292dd1
• NDC: 61748-303
• Product Type: Human Prescription Drug
• Proprietary Name: Myorisan
• Generic Name: Isotretinoin
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2015-08-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076485
• Labeler Name: VersaPharm, Inc.
• Substance Name: ISOTRETINOIN
• Active Ingredient Strength: 30 mg/1
• Pharm Classes: Retinoid [EPC],Retinoids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 61748-303-01

5000 CAPSULE, LIQUID FILLED in 1 BAG (61748-303-01)

• Marketing Start Date: 2015-08-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61748-303-01 [61748030301]

Myorisan CAPSULE, LIQUID FILLED

• Marketing Category: ANDA
• Application Number: ANDA076485
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-08-26

NDC 61748-303-11 [61748030311]

Myorisan CAPSULE, LIQUID FILLED

• Marketing Category: ANDA
• Application Number: ANDA076485
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-08-26

NDC 61748-303-13 [61748030313]

Myorisan CAPSULE, LIQUID FILLED

• Marketing Category: ANDA
• Application Number: ANDA076485
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-08-26

Drug Details

Active Ingredients

Ingredient	Strength
ISOTRETINOIN	30 mg/1

OpenFDA Data

• SPL SET ID: 51ff6346-9256-4c01-9f52-417d13f2df05
• Manufacturer:
  • VersaPharm, Inc. An Akorn Company
• UNII:
  • EH28UP18IF
• RxNorm Concept Unique ID - RxCUI:
  • 197843
  • 403930
  • 197845
  • 197844
  • 1242615
  • 1242613
  • 1242611
  • 1663728

Pharmacological Class

• Retinoid [EPC]
• Retinoids [CS]
• Retinoid [EPC]
• Retinoids [CS]

Medicade Reported Pricing

61748030313 MYORISAN 30 MG CAPSULE

Pricing Unit: EA | Drug Type:

61748030311 MYORISAN 30 MG CAPSULE

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Myorisan" or generic name "Isotretinoin"

NDC	Brand Name	Generic Name
61748-302	Myorisan	Myorisan
61748-303	Myorisan	Myorisan
61748-304	Myorisan	Myorisan
61748-301	Myorisan	Myorisan
0378-6611	Amnesteem	isotretinoin
0378-6612	Amnesteem	isotretinoin
0378-6614	Amnesteem	isotretinoin
0555-1054	Claravis	Isotretinoin
0555-1055	Claravis	Isotretinoin
0555-1056	Claravis	Isotretinoin
0555-1057	Claravis	Isotretinoin
0245-0570	Isotretinoin	Isotretinoin
0245-0571	Isotretinoin	Isotretinoin
0245-0573	Isotretinoin	Isotretinoin
0245-0575	Isotretinoin	Isotretinoin