ACCUTANE

Product NDC
72143-234
11-digit product format
721430234
Labeler code
72143
Product ID
72143-234_59a3c0bb-8c7f-4a86-96f0-43d85fe6c0a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ISOTRETINOIN
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
JG Pharma Inc.
Application
ANDA202099
Marketing category
ANDA
Marketing start
2021-01-11
Marketing end
2023-12-31
Substance
ISOTRETINOIN
Active strength
40 mg/1
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72143-234-10EA - Each72143-2348b3e7e19-815b-408f-80eb-5dcbfe26f03712021-02-05
72143-234-30EA - Each72143-234a2b4a8b8-ce47-4faa-be4d-ae61343c78f812021-02-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72143-234-30721430234303 BLISTER PACK in 1 CARTON (72143-234-30) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (72143-234-10) 3 blister pack2021-01-112023-12-31NoNoCurrent