Isotretinoin

Product NDC: 68308-575
11-digit product format: 683080575
Labeler code: 68308
Product ID: 68308-575_52056651-f1ce-4586-9c28-f919591060a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isotretinoin
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Mayne Pharma
Application: ANDA213571
Marketing category: ANDA
Marketing start: 2021-09-03
Substance: ISOTRETINOIN
Active strength: 40 mg/1
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Isotretinoin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ISOTRETINOIN	40 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	EH28UP18IF
Rxcui	197845

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8300c0f6-79a4-735b-88ec-d781bfffdb10	Product name	5	20260305
644afe93-ba9b-4043-8e40-a9fe9af2d5d7	Product name	2	20250616
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
e5fedfa5-6b96-4769-872b-95d1e7f3a85a	Product name	1	20200415
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68308-575-01	Isotretinoin	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10		4
68308-575-30	Isotretinoin	3 in 1 BOX	CAPSULE, LIQUID FILLED	3		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68308-575-01	EA - Each	68308-575	5d66bda1-6352-498c-9d52-c1b7cf6c0b29	1	2021-10-08
68308-575-30	EA - Each	68308-575	6e40b6a8-8c0d-45cb-b644-9d0e68306b31	1	2021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68308-575	ISOTRETINOIN CAPSULE, LIQUID FILLED [MAYNE PHARMA]	4	Current NDC, Legacy NDC, 2 package rows	20221105_72867c88-070f-4608-bfef-cc5225ebce6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197845	ISOtretinoin 40 MG Oral Capsule	PSN	72867c88-070f-4608-bfef-cc5225ebce6d	4
197845	isotretinoin 40 MG Oral Capsule	SCD	72867c88-070f-4608-bfef-cc5225ebce6d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68308-575-01	68308057501	10 in 1 BLISTER PACK						Historical
68308-575-30	68308057530	3 BLISTER PACK in 1 BOX (68308-575-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-575-01)	3 blister pack	2021-09-03	0000-00-00	No	No	Current