NDC 0378-6614

Amnesteem

Isotretinoin

Amnesteem is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Isotretinoin.

• Product ID: 0378-6614_04880ca3-9af8-45c4-8521-db30e375af47
• NDC: 0378-6614
• Product Type: Human Prescription Drug
• Proprietary Name: Amnesteem
• Generic Name: Isotretinoin
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2002-11-11
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075945
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: ISOTRETINOIN
• Active Ingredient Strength: 40 mg/1
• Pharm Classes: Retinoid [EPC],Retinoids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0378-6614-93

3 BLISTER PACK in 1 CARTON (0378-6614-93) > 10 CAPSULE in 1 BLISTER PACK (0378-6614-85)

• Marketing Start Date: 2002-11-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-6614-85 [00378661485]

Amnesteem CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA075945
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-09-11

NDC 0378-6614-88 [00378661488]

Amnesteem CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA075945
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2002-11-11
• Marketing End Date: 2013-07-24

NDC 0378-6614-93 [00378661493]

Amnesteem CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA075945
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2002-11-11

Drug Details

Active Ingredients

Ingredient	Strength
ISOTRETINOIN	40 mg/1

OpenFDA Data

• SPL SET ID: b2cb63c9-f825-4991-9a2c-6260f1bbcc2c
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • EH28UP18IF
• RxNorm Concept Unique ID - RxCUI:
  • 404058
  • 197843
  • 197845
  • 197844
  • 404064
  • 404061

Pharmacological Class

• Retinoid [EPC]
• Retinoids [CS]

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

NDC	Brand Name	Generic Name
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