APREMILAST

Product NDC: 60219-1410
11-digit product format: 602191410
Labeler code: 60219
Product ID: 60219-1410_ee9b2224-736a-4dd1-8e8f-6795bf73300e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: APREMILAST
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA211782
Marketing category: ANDA
Marketing start: 2021-07-05
Marketing end: 0000-00-00
Substance: APREMILAST
Active strength: 30 mg/1
Pharmacologic classes: Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60219-1410		D	Discontinued by firm		2026-08-03
excluded package	package	60219-1410	60219-1410-6	D	Discontinued by firm		2026-08-03

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 · 18 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
2025-02-02 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	60219-1410-6	`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	60219-1410-6	`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	60219-1410-6	`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	60219-1410-6	`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	60219-1410-6	`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	60219-1410-6	`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	60219-1410-6	`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	60219-1410-6	`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	60219-1410-6	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A211782-001	APREMILAST	APREMILAST	10MG	TABLET / ORAL	2021-06-30
A211782-002	APREMILAST	APREMILAST	20MG	TABLET / ORAL	2021-06-30
A211782-003	APREMILAST	APREMILAST	30MG	TABLET / ORAL	2021-06-30

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 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A211782-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211782-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211782-003	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60219-1410-6	2025-02-18	C162847	48780-1	f386c649-f4d6-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use APREMILAST TABLETS safely and effectively. See full prescribing information for APREMILAST TABLETS. APREMILAST tablets, for oral use Initial U.S. Approval: 2014
60219-1410-6	2023-01-30	C162847	48780-1	f386c649-f4d6-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use APREMILAST TABLETS safely and effectively. See full prescribing information for APREMILAST TABLETS. APREMILAST tablets, for oral use Initial U.S. Approval: 2014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60219-1410	APREMILAST KIT APREMILAST TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]	8	Legacy NDC	20250223_6b37f813-113f-48f3-904c-7d14401ab13d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UP7QBP99PN	APREMILAST	608141-41-9	APREMILAST

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60219-1410-6	60219141006	60 TABLET, FILM COATED in 1 BOTTLE (60219-1410-6)	2021-07-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
APREMILAST	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals Private Limited	2025-02-19	HUMAN PRESCRIPTION DRUG LABEL	8