ACCUTANE

Product NDC
72143-233
11-digit product format
721430233
Labeler code
72143
Product ID
72143-233_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
2024-01-31
Substance
ISOTRETINOIN
Active strength
30 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
72143-233-10EA - Each72143-2330ab463d1-c794-472a-9297-c4279c4e353e12021-02-05
72143-233-30EA - Each72143-233e02c901b-dcdf-4cb5-bd2e-41f7dbaf486612021-02-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72143-233-30721430233303 BLISTER PACK in 1 CARTON (72143-233-30) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (72143-233-10) 3 blister pack2021-01-112024-01-31NoNoCurrent