Abstral

Product NDC: 57881-336
11-digit product format: 578810336
Labeler code: 57881
Product ID: 57881-336_621fd88b-b921-47a2-94bd-a778d6005353
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fentanyl citrate
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Galena Biopharma, Inc.
Application: NDA022510
Marketing category: NDA
Marketing start: 2013-08-08
Marketing end: 0000-00-00
Substance: FENTANYL CITRATE
Active strength: 600 ug/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2019-12-31
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	57881-336		I	Inactivated by FDA		2026-10-05
excluded package	package	57881-336	57881-336-32	I	Inactivated by FDA		2026-10-05

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 · 42 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	57881-336-32	`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	57881-336-32	`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	57881-336-32	`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	57881-336-32	`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	57881-336-32	`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	57881-336-32	`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	57881-336-32	`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	57881-336-32	`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	57881-336-32	`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	57881-336-32	`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	57881-336-32	`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	57881-336-32	`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	57881-336-32	`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	57881-336-32	`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	57881-336-32	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	57881-336-32	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	57881-336-32	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	57881-336-32	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	57881-336-32	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	57881-336-32	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	57881-336-32	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022510-001	ABSTRAL	FENTANYL CITRATE	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07
N022510-002	ABSTRAL	FENTANYL CITRATE	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07
N022510-003	ABSTRAL	FENTANYL CITRATE	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07
N022510-004	ABSTRAL	FENTANYL CITRATE	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07
N022510-005	ABSTRAL	FENTANYL CITRATE	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07
N022510-006	ABSTRAL	FENTANYL CITRATE	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07

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 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022510-001	ABSTRAL	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022510-002	ABSTRAL	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022510-003	ABSTRAL	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022510-004	ABSTRAL	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022510-005	ABSTRAL	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022510-006	ABSTRAL	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022510-001	ABSTRAL	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022510-002	ABSTRAL	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022510-003	ABSTRAL	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022510-004	ABSTRAL	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022510-005	ABSTRAL	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022510-006	ABSTRAL	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022510-001	ABSTRAL	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022510-002	ABSTRAL	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022510-003	ABSTRAL	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022510-004	ABSTRAL	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022510-005	ABSTRAL	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022510-006	ABSTRAL	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022510-001	ABSTRAL	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022510-002	ABSTRAL	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022510-003	ABSTRAL	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022510-004	ABSTRAL	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022510-005	ABSTRAL	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022510-006	ABSTRAL	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022510-001	ABSTRAL	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022510-002	ABSTRAL	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022510-003	ABSTRAL	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022510-004	ABSTRAL	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022510-005	ABSTRAL	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022510-006	ABSTRAL	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022510-001	ABSTRAL	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022510-002	ABSTRAL	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022510-003	ABSTRAL	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022510-004	ABSTRAL	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022510-005	ABSTRAL	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022510-006	ABSTRAL	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022510-001	ABSTRAL	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022510-002	ABSTRAL	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022510-003	ABSTRAL	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022510-004	ABSTRAL	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / SUBLINGUAL	RLD	2011-01-07	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	N022510-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022510-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022510-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022510-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022510-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022510-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022510-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022510-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022510-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022510-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022510-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022510-006	AB	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022510-001	6759059	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-001	6761910	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-001	7910132	2019-09-24	U-767	Drug product	2011-04-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-002	6759059	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-002	6761910	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-002	7910132	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-003	6759059	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-003	6761910	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-003	7910132	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-004	6759059	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-004	6761910	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-004	7910132	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-005	6759059	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-005	6761910	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-005	7910132	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-006	6759059	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-006	6761910	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022510-006	7910132	2019-09-24	U-767	Drug product		`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022510-001	6759059	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-001	6761910	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-001	7910132	2019-09-24	U-767	Drug product	2011-04-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-002	6759059	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-002	6761910	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-002	7910132	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-003	6759059	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-003	6761910	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-003	7910132	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-004	6759059	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-004	6761910	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-004	7910132	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-005	6759059	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-005	6761910	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-005	7910132	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-006	6759059	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-006	6761910	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022510-006	7910132	2019-09-24	U-767	Drug product		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022510-001	6759059	2019-09-24	U-767	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022510-001	6761910	2019-09-24	U-767	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022510-001	7910132	2019-09-24	U-767	Drug product	2011-04-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022510-002	6759059	2019-09-24	U-767	Drug product		`b00525d2431f…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77d14d2b-b9bf-4254-8dd6-c60dedb281d3	Product name	1	20231002
a8df478d-5b88-9654-981b-87dff14dda8b	Product name	2	20190801
e9b48db2-e05b-8c2d-e4ac-a5a2efb26b57	Product name	2	20180118
bb365072-425e-ca0a-021e-fd8b78162502	Product name	2	20161228
339915c8-cc8f-ceb4-1d3f-5ea267d21ea6	Product name	2	20160104
739fa0ac-b690-63c4-9904-e20dffbf78f9	Product name	1	20140508
7763fcbb-367d-ed06-b37f-e1529b6241be	Product name	1	20140508
d9ff6610-5d2e-d5c8-8a19-867d4a1efb77	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57881-336-32	2020-01-31	C162847	48780-1	9d75b9d0-85c0-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ABSTRAL safely and effectively. See full prescribing information for ABSTRAL. ABSTRAL ® (fentanyl) sublingual tablets CII Initial U.S. Approval: 1968

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57881-336-04	Abstral	4 in 1 BLISTER PACK	TABLET	4		2
57881-336-32	Abstral	8 in 1 CARTON	TABLET	8		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57881-336-04	EA - Each	57881-336	90679a82-237a-4c5d-a6c2-aa25507dd247	1	2013-11-04
57881-336-32	EA - Each	57881-336	1de18243-fc2f-4582-b1ed-5b2b42559bc7	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
fentanyl citrate	ACTIVE INGREDIENT	MUN5LYG46H	ABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]	2
fentanyl	ACTIVE MOIETY	UF599785JZ	ABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]	2
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	ABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]	2
mannitol	INACTIVE INGREDIENT	3OWL53L36A	ABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57881-336	ABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]	2	Legacy NDC, 2 package rows	20150114_f969e2bc-6297-4e29-89d3-a3685a2c7c6b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MUN5LYG46H	FENTANYL CITRATE	990-73-8	FENTANYL CITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1053651	ABSTRAL 100 MCG Sublingual Tablet	PSN	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053654	ABSTRAL 200 MCG Sublingual Tablet	PSN	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053657	ABSTRAL 300 MCG Sublingual Tablet	PSN	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053660	ABSTRAL 400 MCG Sublingual Tablet	PSN	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053663	ABSTRAL 600 MCG Sublingual Tablet	PSN	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053666	ABSTRAL 800 MCG Sublingual Tablet	PSN	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053647	fentaNYL 100 MCG Sublingual Tablet	PSN	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053652	fentaNYL 200 MCG Sublingual Tablet	PSN	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053655	fentaNYL 300 MCG Sublingual Tablet	PSN	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053658	fentaNYL 400 MCG Sublingual Tablet	PSN	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053661	fentaNYL 600 MCG Sublingual Tablet	PSN	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053664	fentaNYL 800 MCG Sublingual Tablet	PSN	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053651	fentanyl 0.1 MG Sublingual Tablet [Abstral]	SBD	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053654	fentanyl 0.2 MG Sublingual Tablet [Abstral]	SBD	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053657	fentanyl 0.3 MG Sublingual Tablet [Abstral]	SBD	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053660	fentanyl 0.4 MG Sublingual Tablet [Abstral]	SBD	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053663	fentanyl 0.6 MG Sublingual Tablet [Abstral]	SBD	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053666	fentanyl 0.8 MG Sublingual Tablet [Abstral]	SBD	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053647	fentanyl 0.1 MG Sublingual Tablet	SCD	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053652	fentanyl 0.2 MG Sublingual Tablet	SCD	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053655	fentanyl 0.3 MG Sublingual Tablet	SCD	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053658	fentanyl 0.4 MG Sublingual Tablet	SCD	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053661	fentanyl 0.6 MG Sublingual Tablet	SCD	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053664	fentanyl 0.8 MG Sublingual Tablet	SCD	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053651	Abstral (as fentanyl citrate) 100 MCG Sublingual Tablet	SY	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053654	Abstral (as fentanyl citrate) 200 MCG Sublingual Tablet	SY	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053657	Abstral (as fentanyl citrate) 300 MCG Sublingual Tablet	SY	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053660	Abstral (as fentanyl citrate) 400 MCG Sublingual Tablet	SY	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053663	Abstral (as fentanyl citrate) 600 MCG Sublingual Tablet	SY	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053666	Abstral (as fentanyl citrate) 800 MCG Sublingual Tablet	SY	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053651	Abstral 0.1 MG Sublingual Tablet	SY	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053654	Abstral 0.2 MG Sublingual Tablet	SY	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053657	Abstral 0.3 MG Sublingual Tablet	SY	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053660	Abstral 0.4 MG Sublingual Tablet	SY	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053663	Abstral 0.6 MG Sublingual Tablet	SY	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053666	Abstral 0.8 MG Sublingual Tablet	SY	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053647	fentanyl (as fentanyl citrate) 100 MCG Sublingual Tablet	SY	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053652	fentanyl 200 MCG Sublingual Tablet	SY	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053655	fentanyl 300 MCG Sublingual Tablet	SY	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053658	fentanyl 400 MCG Sublingual Tablet	SY	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053661	fentanyl 600 MCG Sublingual Tablet	SY	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2
1053664	fentanyl 800 MCG Sublingual Tablet	SY	f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
57881-336-04	57881033604	4 in 1 BLISTER PACK	Historical
57881-336-32	57881033632	8 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Abstral	Galena Biopharma, Inc. \| Pharmaceutics International, Inc.	2014-11-30	HUMAN PRESCRIPTION DRUG LABEL	2