Dehydrated Alcohol

Product NDC: 82983-426
11-digit product format: 829830426
Labeler code: 82983
Product ID: 82983-426_be0bec74-c6a7-49e7-931f-69d289cb366f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alcohol
Dosage form: INJECTION, SOLUTION
Route: PERCUTANEOUS
Labeler: Ajenat Pharmaceuticals LLC
Application: NDA207987
Marketing category: NDA
Marketing start: 2025-08-15
Substance: ALCOHOL
Active strength: 1 mL/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N207987-001	ABLYSINOL	DEHYDRATED ALCOHOL	99% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21
N207987-002	ABLYSINOL	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL	AP	RLD, RS	2018-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N207987-002	AP

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N207987-001	ABLYSINOL	99% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL	AP	RLD, RS	2018-06-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207987-001	ABLYSINOL	99% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL	AP	RLD, RS	2018-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207987-001	ABLYSINOL	99% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL	AP	RLD, RS	2018-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207987-001	ABLYSINOL	99% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL	AP	RLD, RS	2018-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207987-001	ABLYSINOL	99% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL	AP	RLD, RS	2018-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207987-001	ABLYSINOL	99% (1ML)	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL		RLD, RS	2018-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207987-001	ABLYSINOL	99% (1ML)	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL		RLD, RS	2018-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207987-001	ABLYSINOL	99% (1ML)	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL		RLD, RS	2018-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207987-001	ABLYSINOL	99% (1ML)	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL		RLD, RS	2018-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207987-001	ABLYSINOL	99% (1ML)	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL		RLD, RS	2018-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207987-001	ABLYSINOL	99% (1ML)	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL		RLD, RS	2018-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207987-001	ABLYSINOL	99% (1ML)	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL		RLD, RS	2018-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207987-001	ABLYSINOL	99% (1ML)	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL		RLD, RS	2018-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207987-001	ABLYSINOL	99% (1ML)	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL		RLD, RS	2018-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207987-001	ABLYSINOL	99% (1ML)	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL		RLD, RS	2018-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207987-001	ABLYSINOL	99% (1ML)	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL		RLD, RS	2018-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207987-001	ABLYSINOL	99% (1ML)	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL		RLD, RS	2018-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207987-001	ABLYSINOL	99% (1ML)	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL		RLD, RS	2018-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207987-001	ABLYSINOL	99% (1ML)	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL		RLD, RS	2018-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207987-001	ABLYSINOL	99% (1ML)	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207987-002	ABLYSINOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL		RLD, RS	2018-06-21	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N207987-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207987-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207987-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207987-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207987-002	AP	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N207987-002	AP	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207987-001	ODE-192	2025-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207987-002	ODE-192	2025-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207987-001	ODE-192	2025-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207987-002	ODE-192	2025-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207987-001	ODE-192	2025-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207987-002	ODE-192	2025-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207987-001	ODE-192	2025-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207987-002	ODE-192	2025-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207987-001	ODE-192	2025-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207987-002	ODE-192	2025-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207987-001	ODE-192	2025-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207987-002	ODE-192	2025-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207987-001	ODE-192	2025-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207987-002	ODE-192	2025-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207987-001	ODE-192	2025-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207987-002	ODE-192	2025-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207987-001	ODE-192	2025-06-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207987-002	ODE-192	2025-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207987-001	ODE-192	2025-06-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207987-002	ODE-192	2025-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207987-001	ODE-192	2025-06-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207987-002	ODE-192	2025-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207987-001	ODE-192	2025-06-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207987-002	ODE-192	2025-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207987-001	ODE-192	2025-06-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207987-002	ODE-192	2025-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207987-001	ODE-192	2025-06-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207987-002	ODE-192	2025-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207987-001	ODE-192	2025-06-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207987-002	ODE-192	2025-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207987-001	ODE-192	2025-06-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207987-002	ODE-192	2025-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207987-001	ODE-192	2025-06-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207987-002	ODE-192	2025-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207987-001	ODE-192	2025-06-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207987-002	ODE-192	2025-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207987-001	ODE-192	2025-06-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207987-002	ODE-192	2025-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207987-001	ODE-192	2025-06-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207987-002	ODE-192	2025-06-21	`87673890dc5c…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALCOHOL	1 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3K9958V90M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2048982	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
636d6421-cadf-42b3-a431-ba40c06e36d2	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82983-426-01	Dehydrated Alcohol	5 mL in 1 VIAL	INJECTION, SOLUTION	5		2
82983-426-10	Dehydrated Alcohol	10 in 1 CARTON	INJECTION, SOLUTION	10		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82983-426-01	ML - Milliliter	82983-426	a27d7901-6d5d-43f1-af8b-25f42dd643fe	1	2026-01-08
82983-426-10	ML - Milliliter	82983-426	e2ff2520-030a-4689-895c-7946d98a35d1	1	2026-01-08

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
Dehydrated Alcohol	ALCOHOL	BPI Labs, LLC	314b1dab-8f4f-49ae-a105-f974842818b8	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207987 application number: NDA207987
Dehydrated Alcohol	ALCOHOL	Ajenat Pharmaceuticals LLC	636d6421-cadf-42b3-a431-ba40c06e36d2	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207987 application number: NDA207987 ndc (product): 82983-426

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2048982	ethanol 99 % in 5 ML Injection	PSN	636d6421-cadf-42b3-a431-ba40c06e36d2	2
2048982	5 ML ethanol 0.99 ML/ML Injection	SCD	636d6421-cadf-42b3-a431-ba40c06e36d2	2
2048982	ethanol 99 % per 5 ML Injection	SY	636d6421-cadf-42b3-a431-ba40c06e36d2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82983-426-01	82983042601	5 mL in 1 VIAL	5 ml				Historical
82983-426-10	82983042610	10 VIAL in 1 CARTON (82983-426-10) / 5 mL in 1 VIAL (82983-426-01)	10 vial	2025-08-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dehydrated Alcohol	Ajenat Pharmaceuticals LLC \| BPI Labs, LLC	2025-12-29	HUMAN PRESCRIPTION DRUG LABEL	2