FDA.reportPublic FDA data

Dehydrated Alcohol

Product NDC
83634-306
11-digit product format
836340306
Labeler code
83634
Product ID
83634-306_c7701c7b-851f-48a3-b8db-8492cd975798
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alcohol
Dosage form
INJECTION, SOLUTION
Route
PERCUTANEOUS
Labeler
Avenacy, LLC
Application
ANDA219569
Marketing category
ANDA
Marketing start
2025-07-17
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219569-001DEHYDRATED ALCOHOLDEHYDRATED ALCOHOL99% (5ML)SOLUTION / INTRA-ARTERIALAP2025-07-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219569-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A219569-001DEHYDRATED ALCOHOL99% (5ML)SOLUTION / INTRA-ARTERIALAP2025-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219569-001DEHYDRATED ALCOHOL99% (5ML)SOLUTION / INTRA-ARTERIALAP2025-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A219569-001DEHYDRATED ALCOHOL99% (5ML)SOLUTION / INTRA-ARTERIALAP2025-07-096a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219569-001DEHYDRATED ALCOHOL99% (5ML)SOLUTION / INTRA-ARTERIALAP2025-07-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219569-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219569-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219569-001AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219569-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Dehydrated Alcohol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL1 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
90e92d21-9821-4132-b17d-d98d523f12e8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83634-306-05Dehydrated Alcohol5 in 1 CARTONINJECTION, SOLUTION52
83634-306-41Dehydrated Alcohol5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83634-306-05ML - Milliliter83634-306753ca970-710c-459e-9f71-0c836ed4497912025-08-11
83634-306-41ML - Milliliter83634-306f574a346-c20f-44d5-8207-b342cc702b0212025-08-11

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dehydrated AlcoholALCOHOLAvenacy, LLC90e92d21-9821-4132-b17d-d98d523f12e82026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219569
application number: ANDA219569
ndc (product): 83634-306
Dehydrated AlcoholALCOHOLSolupharm Pharmazeutische Erzeugnisse GmbH372d3eb5-78ee-414c-a146-4a19e22661842025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219569
application number: ANDA219569
Dehydrated AlcoholDEHYDRATED ALCOHOLIngenus Pharmaceuticals, LLC1d5ec6f9-d58f-4651-a4a1-93fec13fd4382025-07-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219569
application number: ANDA219569

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2048982ethanol 99 % in 5 ML InjectionPSN90e92d21-9821-4132-b17d-d98d523f12e82
20489825 ML ethanol 0.99 ML/ML InjectionSCD90e92d21-9821-4132-b17d-d98d523f12e82
2048982ethanol 99 % per 5 ML InjectionSY90e92d21-9821-4132-b17d-d98d523f12e82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83634-306-05836340306055 VIAL, SINGLE-DOSE in 1 CARTON (83634-306-05) / 5 mL in 1 VIAL, SINGLE-DOSE (83634-306-41) 2025-07-17NoNoCurrent
83634-306-06836340306061 VIAL, SINGLE-DOSE in 1 CARTON (83634-306-06) / 5 mL in 1 VIAL, SINGLE-DOSE (83634-306-41)2026-07-310Current
83634-306-41836340306415 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical