NDC 72143-251

ACCUTANE

Isotretinoin

ACCUTANE is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Jg Pharma Inc.. The primary component is Isotretinoin.

Product ID72143-251_78f92a10-c27d-4238-8dc5-771a69c29119
NDC72143-251
Product TypeHuman Prescription Drug
Proprietary NameACCUTANE
Generic NameIsotretinoin
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date2022-08-01
Marketing CategoryANDA /
Application NumberANDA202099
Labeler NameJG Pharma Inc.
Substance NameISOTRETINOIN
Active Ingredient Strength10 mg/1
Pharm ClassesRetinoid [EPC], Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 72143-251-30

3 BLISTER PACK in 1 CARTON (72143-251-30) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Marketing Start Date2022-08-01
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
72143-232ACCUTANEACCUTANE
72143-233ACCUTANEACCUTANE
72143-234ACCUTANEACCUTANE
72143-231ACCUTANEACCUTANE
0378-6611Amnesteemisotretinoin
0378-6612Amnesteemisotretinoin
0378-6614Amnesteemisotretinoin
0555-1054ClaravisIsotretinoin
0555-1055ClaravisIsotretinoin
0555-1056ClaravisIsotretinoin
0555-1057ClaravisIsotretinoin
0245-0570IsotretinoinIsotretinoin
0245-0571IsotretinoinIsotretinoin
0245-0573IsotretinoinIsotretinoin
0245-0575IsotretinoinIsotretinoin

Trademark Results [ACCUTANE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACCUTANE
ACCUTANE
87003385 5788124 Live/Registered
T.BERRY BIOTECH, LLC
2016-04-16
ACCUTANE
ACCUTANE
72443249 0966924 Dead/Cancelled
HOFFMANN-LA ROCHE INC.
1972-12-08

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