NDC 68308-784-01 - Isotretinoin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 68308-784
Requested NDC: 68308-784-01
Package NDCs from labels: 68308-784-01, 68308-784-30
Manufacturer: Mayne Pharma
Effective date: 2024-06-26
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Isotretinoin - Mayne Pharma	Mayne Pharma	2024-06-26	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68308-784-01	Isotretinoin	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10		4
68308-784-30	Isotretinoin	3 in 1 BOX	CAPSULE, LIQUID FILLED	3		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68308-784	ISOTRETINOIN CAPSULE, LIQUID FILLED [MAYNE PHARMA]	4	Current NDC, 2 package rows	20240628_0114567b-3bac-490d-b9eb-03a6c5d90935.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68308-784-01	EA - Each	68308-784	462faae8-2883-4ab8-904e-aad7aa616542	1	2024-01-04
68308-784-30	EA - Each	68308-784	a238822f-acae-4f2f-8696-c46354a4b72d	1	2024-01-04

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 284 of 289 · 5,777 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DEFENSE Hand Sanitizer	ISOPROPYL ALCOHOL	Walla Walla Environmental, Inc.	af498f92-6029-46b9-e053-2995a90a1c6d	2022-08-31	Warnings	Exact identifier unii: ND2M416302
Intralipid	I.V. FAT EMULSION	Baxter Healthcare CORP	069460a5-3e9a-428f-b2dc-3405690f4fd7	2022-07-25	Boxed warning, Adverse reactions	Exact identifier unii: 241ATL177A
Intralipid	I.V. FAT EMULSION	Baxter Healthcare Corporation	55609586-f0b4-42e6-8dd9-cd090afb5dca	2022-07-21	Boxed warning, Adverse reactions	Exact identifier unii: 241ATL177A
Intralipid	I.V. FAT EMULSION	Baxter Healthcare Corporation	a69c82da-15ba-4d4d-8d7f-871dc3981eb8	2022-07-21	Boxed warning, Adverse reactions	Exact identifier unii: 241ATL177A
Intralipid	I. V. FAT EMULSION	Baxter Healthcare Corporation	dd269651-30e8-43f0-880f-484346eaafeb	2022-07-21	Boxed warning, Adverse reactions	Exact identifier unii: 241ATL177A
Glycerinum	GLYCERINUM	Hahnemann Laboratories, INC.	e34f8796-85b5-2946-e053-2995a90a251e	2022-07-08		Exact identifier unii: PDC6A3C0OX
REFRESH Optive Mega-3	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80	Allergan, Inc.	c5f2b3f2-2071-45bd-a010-67f848bc0233	2022-06-30	Warnings	Exact identifier unii: PDC6A3C0OX
Ethylicum (ETOH, aka Alcoholus)	ETHYLICUM (ETOH, AKA ALCOHOLUS)	Hahnemann Laboratories, INC.	e1fef03a-ed76-4294-e053-2995a90aee67	2022-06-21		Exact identifier unii: 3K9958V90M
Miracle FootCream Lavender	UREA, GLYCERIN, ALOE, DISODIUM EDTA	Aloe Vera Korea Co.,Ltd.	db520c80-2a2a-5eb1-e053-2995a90a5bb4	2022-03-28	Warnings	Exact identifier unii: 7FLD91C86K unii: PDC6A3C0OX
Miracle FootCream Lemon	UREA, GLYCERIN, ALOE, DISODIUM EDTA	Aloe Vera Korea Co.,Ltd.	db525c63-29fd-2033-e053-2995a90a56b9	2022-03-28	Warnings	Exact identifier unii: 7FLD91C86K unii: PDC6A3C0OX
Alcohol Prep Pad	ISOPROPYL ALCOHOL	Shandong Haiyan Medical Manufacture Co., Ltd.	1a117840-22d0-4a88-b1a6-e43162a444ab	2022-03-19	Warnings	Exact identifier unii: ND2M416302
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm Ivory	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	97e7ece8-a705-4988-ba52-6d3f11573521	2021-12-01	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Chestnut	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	6a44f926-11b4-4bc4-8d5d-721a89c4f0cc	2021-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Hazelnut	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	b58af664-b0fd-4585-8417-7c20954d7aff	2021-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Umber	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	7bbd1334-fae8-4274-b927-a099af764345	2021-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cedar	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	970571f9-3d6b-46ae-a668-745de1911fa2	2021-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Wheat	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	542e1b2e-f63c-466b-b5ac-6c147a0e9dec	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	21b65c12-6f67-4053-9508-6b2709cc1fb8	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	8ea4c470-ebd5-448e-b72a-ccd1113de0ab	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Honey	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	fd9689a4-21d1-49f0-bf59-b8e1da72cd16	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.