Myorisan

Product NDC: 61748-301
11-digit product format: 617480301
Labeler code: 61748
Product ID: 61748-301_3e34f054-8b03-4d79-821c-593120c49ea2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: isotretinoin
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Akorn Operating Company LLC
Application: ANDA076485
Marketing category: ANDA
Marketing start: 2012-05-01
Marketing end: 0000-00-00
Substance: ISOTRETINOIN
Active strength: 10 mg/1
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61748-301		I	Inactivated by FDA	2026-08-11
excluded package	package	61748-301	61748-301-01	I	Inactivated by FDA	2026-08-11
excluded package	package	61748-301	61748-301-11	I	Inactivated by FDA	2026-08-11
excluded package	package	61748-301	61748-301-13	I	Inactivated by FDA	2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61748-301-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61748-301-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61748-301-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61748-301-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61748-301-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61748-301-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61748-301-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61748-301-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61748-301-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61748-301-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61748-301-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61748-301-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61748-301-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61748-301-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61748-301-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61748-301-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61748-301-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61748-301-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61748-301-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61748-301-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61748-301-13	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61748-301-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61748-301-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61748-301-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61748-301-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61748-301-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61748-301-13	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61748-301-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61748-301-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61748-301-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61748-301-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61748-301-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61748-301-13	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61748-301-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61748-301-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61748-301-13	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61748-301-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61748-301-11	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61748-301-13	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61748-301-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61748-301-11	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61748-301-13	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61748-301-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61748-301-11	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61748-301-13	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076485-001	MYORISAN	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB1	2012-01-19
A076485-002	MYORISAN	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB1	2012-01-19
A076485-003	MYORISAN	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB1	2012-01-19
A076485-004	MYORISAN	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB1	2015-08-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A076485-001	AB1
A076485-002	AB1
A076485-003	AB1
A076485-004	AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076485-001	MYORISAN	10MG	CAPSULE / ORAL	AB1	2012-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076485-002	MYORISAN	20MG	CAPSULE / ORAL	AB1	2012-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076485-003	MYORISAN	40MG	CAPSULE / ORAL	AB1	2012-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076485-004	MYORISAN	30MG	CAPSULE / ORAL	AB1	2015-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076485-001	MYORISAN	10MG	CAPSULE / ORAL	AB1	2012-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076485-002	MYORISAN	20MG	CAPSULE / ORAL	AB1	2012-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076485-003	MYORISAN	40MG	CAPSULE / ORAL	AB1	2012-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076485-004	MYORISAN	30MG	CAPSULE / ORAL	AB1	2015-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076485-001	MYORISAN	10MG	CAPSULE / ORAL	AB1	2012-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076485-002	MYORISAN	20MG	CAPSULE / ORAL	AB1	2012-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076485-003	MYORISAN	40MG	CAPSULE / ORAL	AB1	2012-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076485-004	MYORISAN	30MG	CAPSULE / ORAL	AB1	2015-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076485-001	MYORISAN	10MG	CAPSULE / ORAL	AB1	2012-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076485-002	MYORISAN	20MG	CAPSULE / ORAL	AB1	2012-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076485-003	MYORISAN	40MG	CAPSULE / ORAL	AB1	2012-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076485-004	MYORISAN	30MG	CAPSULE / ORAL	AB1	2015-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076485-001	MYORISAN	10MG	CAPSULE / ORAL	AB1	2012-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076485-002	MYORISAN	20MG	CAPSULE / ORAL	AB1	2012-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076485-003	MYORISAN	40MG	CAPSULE / ORAL	AB1	2012-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076485-004	MYORISAN	30MG	CAPSULE / ORAL	AB1	2015-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076485-001	MYORISAN	10MG	CAPSULE / ORAL	AB1	2012-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076485-002	MYORISAN	20MG	CAPSULE / ORAL	AB1	2012-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076485-003	MYORISAN	40MG	CAPSULE / ORAL	AB1	2012-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076485-004	MYORISAN	30MG	CAPSULE / ORAL	AB1	2015-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076485-001	MYORISAN	10MG	CAPSULE / ORAL	AB1	2012-01-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076485-002	MYORISAN	20MG	CAPSULE / ORAL	AB1	2012-01-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076485-003	MYORISAN	40MG	CAPSULE / ORAL	AB1	2012-01-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076485-004	MYORISAN	30MG	CAPSULE / ORAL	AB1	2015-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076485-001	MYORISAN	10MG	CAPSULE / ORAL	AB1	2012-01-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076485-002	MYORISAN	20MG	CAPSULE / ORAL	AB1	2012-01-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076485-003	MYORISAN	40MG	CAPSULE / ORAL	AB1	2012-01-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076485-004	MYORISAN	30MG	CAPSULE / ORAL	AB1	2015-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076485-001	MYORISAN	10MG	CAPSULE / ORAL	AB1	2012-01-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076485-002	MYORISAN	20MG	CAPSULE / ORAL	AB1	2012-01-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076485-003	MYORISAN	40MG	CAPSULE / ORAL	AB1	2012-01-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076485-004	MYORISAN	30MG	CAPSULE / ORAL	AB1	2015-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076485-001	MYORISAN	10MG	CAPSULE / ORAL	AB1	2012-01-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076485-002	MYORISAN	20MG	CAPSULE / ORAL	AB1	2012-01-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076485-003	MYORISAN	40MG	CAPSULE / ORAL	AB1	2012-01-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076485-004	MYORISAN	30MG	CAPSULE / ORAL	AB1	2015-08-25	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076485-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076485-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076485-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076485-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076485-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076485-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076485-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076485-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076485-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076485-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076485-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076485-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076485-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076485-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076485-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076485-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076485-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076485-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076485-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076485-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076485-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076485-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076485-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076485-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076485-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076485-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076485-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076485-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076485-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076485-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076485-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076485-004	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076485-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076485-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076485-003	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076485-004	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076485-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076485-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076485-003	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076485-004	AB1	1	`d06236e962d9…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61748-301-01	2024-01-30	C162847	48780-1	1030e364-fd70-111a-e063-dadaa90a10e2	Myorisan ® (isotretinoin capsules, USP) 10 mg, 20 mg, 30 mg, 40 mg
61748-301-11	2024-01-30	C162847	48780-1	1030e364-fd70-111a-e063-dadaa90a10e2	Myorisan ® (isotretinoin capsules, USP) 10 mg, 20 mg, 30 mg, 40 mg
61748-301-13	2024-01-30	C162847	48780-1	1030e364-fd70-111a-e063-dadaa90a10e2	Myorisan ® (isotretinoin capsules, USP) 10 mg, 20 mg, 30 mg, 40 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61748-301-01	Myorisan	5000 in 1 BAG	CAPSULE, LIQUID FILLED	5000	14
61748-301-11	Myorisan	10 in 1 CARTON	CAPSULE, LIQUID FILLED	10	14
61748-301-11	Myorisan	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	14
61748-301-13	Myorisan	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	14
61748-301-13	Myorisan	3 in 1 CARTON	CAPSULE, LIQUID FILLED	3	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61748-301-11	EA - Each	61748-301	d1475b8b-7cba-4a3f-b712-ab0314d403cf	1	2012-07-24
61748-301-13	EA - Each	61748-301	6d7adc5d-03ac-4c12-bf10-fb5a7588afa0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISOTRETINOIN	ACTIVE INGREDIENT	EH28UP18IF	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
ISOTRETINOIN	ACTIVE MOIETY	EH28UP18IF	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
.ALPHA.-TOCOPHEROL, DL-	INACTIVE INGREDIENT	7QWA1RIO01	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
HYDROGENATED SOYBEAN OIL	INACTIVE INGREDIENT	A2M91M918C	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
SHELLAC	INACTIVE INGREDIENT	46N107B71O	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
SOYBEAN OIL	INACTIVE INGREDIENT	241ATL177A	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61748-301	MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [AKORN OPERATING COMPANY LLC]	14	Legacy NDC, 5 package rows	20221220_51ff6346-9256-4c01-9f52-417d13f2df05.zip

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isotretinoin	ISOTRETINOIN	Upsher-Smith Laboratories, LLC	c369e1c3-90c5-4768-9741-56c62253a2c4	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076485 application number: ANDA076485
Isotretinoin	ISOTRETINOIN	Mayne Pharma	0114567b-3bac-490d-b9eb-03a6c5d90935	2024-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076485 application number: ANDA076485

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EH28UP18IF	ISOTRETINOIN	4759-48-2	ISOTRETINOIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197843	ISOtretinoin 10 MG Oral Capsule	PSN	51ff6346-9256-4c01-9f52-417d13f2df05	14
197844	ISOtretinoin 20 MG Oral Capsule	PSN	51ff6346-9256-4c01-9f52-417d13f2df05	14
403930	ISOtretinoin 30 MG Oral Capsule	PSN	51ff6346-9256-4c01-9f52-417d13f2df05	14
197845	ISOtretinoin 40 MG Oral Capsule	PSN	51ff6346-9256-4c01-9f52-417d13f2df05	14
1242611	MYORISAN 10 MG Oral Capsule	PSN	51ff6346-9256-4c01-9f52-417d13f2df05	14
1242613	MYORISAN 20 MG Oral Capsule	PSN	51ff6346-9256-4c01-9f52-417d13f2df05	14
1663728	MYORISAN 30 MG Oral Capsule	PSN	51ff6346-9256-4c01-9f52-417d13f2df05	14
1242615	MYORISAN 40 MG Oral Capsule	PSN	51ff6346-9256-4c01-9f52-417d13f2df05	14
1242611	isotretinoin 10 MG Oral Capsule [Myorisan]	SBD	51ff6346-9256-4c01-9f52-417d13f2df05	14
1242613	isotretinoin 20 MG Oral Capsule [Myorisan]	SBD	51ff6346-9256-4c01-9f52-417d13f2df05	14
1663728	isotretinoin 30 MG Oral Capsule [Myorisan]	SBD	51ff6346-9256-4c01-9f52-417d13f2df05	14
1242615	isotretinoin 40 MG Oral Capsule [Myorisan]	SBD	51ff6346-9256-4c01-9f52-417d13f2df05	14
197843	isotretinoin 10 MG Oral Capsule	SCD	51ff6346-9256-4c01-9f52-417d13f2df05	14
197844	isotretinoin 20 MG Oral Capsule	SCD	51ff6346-9256-4c01-9f52-417d13f2df05	14
403930	isotretinoin 30 MG Oral Capsule	SCD	51ff6346-9256-4c01-9f52-417d13f2df05	14
197845	isotretinoin 40 MG Oral Capsule	SCD	51ff6346-9256-4c01-9f52-417d13f2df05	14
1242611	Myorisan 10 MG Oral Capsule	SY	51ff6346-9256-4c01-9f52-417d13f2df05	14
1242613	Myorisan 20 MG Oral Capsule	SY	51ff6346-9256-4c01-9f52-417d13f2df05	14
1663728	Myorisan 30 MG Oral Capsule	SY	51ff6346-9256-4c01-9f52-417d13f2df05	14
1242615	Myorisan 40 MG Oral Capsule	SY	51ff6346-9256-4c01-9f52-417d13f2df05	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61748-301-01	61748030101	5000 CAPSULE, LIQUID FILLED in 1 BAG (61748-301-01)		2012-05-01	0000-00-00	No	No	Current
61748-301-11	61748030111	10 BLISTER PACK in 1 CARTON (61748-301-11) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	10 blister pack	2012-05-01	0000-00-00	No	No	Current
61748-301-13	61748030113	3 BLISTER PACK in 1 CARTON (61748-301-13) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	3 blister pack	2012-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Myorisan ® (isotretinoin capsules, USP) 10 mg, 20 mg, 30 mg, 40 mg	Akorn Operating Company LLC \| Swiss Caps AG \| Douglas Manufacturing Ltd	2022-12-19	HUMAN PRESCRIPTION DRUG LABEL	14