NDC 69238-1176

Isotretinoin

Isotretinoin

Isotretinoin is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Ny Llc. The primary component is Isotretinoin.

• Product ID: 69238-1176_03637af3-4595-457a-9da8-c51600d4b338
• NDC: 69238-1176
• Product Type: Human Prescription Drug
• Proprietary Name: Isotretinoin
• Generic Name: Isotretinoin
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2017-10-02
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207792
• Labeler Name: Amneal Pharmaceuticals NY LLC
• 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 69238-1176-3

3 BLISTER PACK in 1 CARTON (69238-1176-3) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1176-1)

• Marketing Start Date: 2017-10-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69238-1176-1 [69238117601]

Isotretinoin CAPSULE, LIQUID FILLED

• Marketing Category: ANDA
• Application Number: ANDA207792
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-10-02

NDC 69238-1176-3 [69238117603]

Isotretinoin CAPSULE, LIQUID FILLED

• Marketing Category: ANDA
• Application Number: ANDA207792
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-10-02

Drug Details

Active Ingredients

Ingredient	Strength
ISOTRETINOIN	40 mg/1

OpenFDA Data

• SPL SET ID: c2917c3d-3499-48a0-ba53-120cb979195d
• Manufacturer:
  • Amneal Pharmaceuticals LLC
• UNII:
  • EH28UP18IF
• RxNorm Concept Unique ID - RxCUI:
  • 197843
  • 403930
  • 197845
  • 197844
• UPC Code:
  • 0369238117431
  • 0369238117417
  • 0369238117639
  • 0369238117530
  • 0369238101737
  • 0369238101713
  • 0369238117516
  • 0369238117615

Pharmacological Class

• Retinoid [EPC]
• Retinoids [CS]

Medicade Reported Pricing

69238117603 ISOTRETINOIN 40 MG CAPSULE

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
0245-0570	Isotretinoin	Isotretinoin
0245-0571	Isotretinoin	Isotretinoin
0245-0573	Isotretinoin	Isotretinoin
0245-0575	Isotretinoin	Isotretinoin
69238-1017	Isotretinoin	Isotretinoin
69238-1174	Isotretinoin	Isotretinoin
69238-1175	Isotretinoin	Isotretinoin
69238-1176	Isotretinoin	Isotretinoin
57664-021	Isotretinoin	Isotretinoin
57664-023	Isotretinoin	Isotretinoin
57664-025	Isotretinoin	Isotretinoin
57664-020	Isotretinoin	Isotretinoin
57664-022	Isotretinoin	Isotretinoin
57664-024	Isotretinoin	Isotretinoin
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