Dehydrated Alcohol

Product NDC: 50742-539
Requested package NDC: 50742-539-10
11-digit product format: 507420539
Labeler code: 50742
Product ID: 50742-539_149c50c5-59ad-4602-ad9e-58ad960eb91d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dehydrated alcohol
Dosage form: INJECTION, SOLUTION
Route: PERCUTANEOUS
Labeler: Ingenus Pharmaceuticals, LLC
Application: ANDA219569
Marketing category: ANDA
Marketing start: 2025-07-09
Substance: DEHYDRATED ALCOHOL
Active strength: 5 mL/5mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A219569-001	DEHYDRATED ALCOHOL	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL	AP		2025-07-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219569-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A219569-001	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL	AP	2025-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219569-001	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL	AP	2025-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219569-001	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL	AP	2025-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219569-001	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL	AP	2025-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219569-001	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL	AP	2025-07-09	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219569-001	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION / INTRA-ARTERIAL	AP	2025-07-09	`a50c72e98297…`

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	A219569-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219569-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219569-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219569-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219569-001	AP	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219569-001	AP	1	`a50c72e98297…`

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
DEHYDRATED ALCOHOL	5 mL/5mL

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
1d5ec6f9-d58f-4651-a4a1-93fec13fd438	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50742-539-01	Dehydrated Alcohol	5 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	5		3
50742-539-10	Dehydrated Alcohol	10 in 1 CARTON	INJECTION, SOLUTION	10		3

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dehydrated Alcohol	ALCOHOL	Avenacy, LLC	90e92d21-9821-4132-b17d-d98d523f12e8	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219569 application number: ANDA219569
Dehydrated Alcohol	ALCOHOL	Solupharm Pharmazeutische Erzeugnisse GmbH	372d3eb5-78ee-414c-a146-4a19e2266184	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219569 application number: ANDA219569
Dehydrated Alcohol	DEHYDRATED ALCOHOL	Ingenus Pharmaceuticals, LLC	1d5ec6f9-d58f-4651-a4a1-93fec13fd438	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219569 application number: ANDA219569 ndc (package): 50742-539-10 ndc (product): 50742-539 ndc11 (package): 50742053910

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2048982	ethanol 99 % in 5 ML Injection	PSN	1d5ec6f9-d58f-4651-a4a1-93fec13fd438	3
2048982	5 ML ethanol 0.99 ML/ML Injection	SCD	1d5ec6f9-d58f-4651-a4a1-93fec13fd438	3
2048982	ethanol 99 % per 5 ML Injection	SY	1d5ec6f9-d58f-4651-a4a1-93fec13fd438	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50742-539-10	50742053910	10 VIAL, GLASS in 1 CARTON (50742-539-10) / 5 mL in 1 VIAL, GLASS (50742-539-01)	2025-07-09	No	No	Current