FDA.reportPublic FDA data

Dehydrated Alcohol

Product NDC
51991-999
11-digit product format
519910999
Labeler code
51991
Product ID
51991-999_5329ec90-465f-42c4-ac98-b5f0d644abfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alcohol
Dosage form
INJECTION, SOLUTION
Route
INTRA-ARTERIAL
Labeler
Breckenridge Pharmaceutical Inc
Application
ANDA219444
Marketing category
ANDA
Marketing start
2025-09-23
Substance
ALCOHOL
Active strength
1 mL/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219444-001DEHYDRATED ALCOHOLDEHYDRATED ALCOHOL99% (5ML)SOLUTION / INTRA-ARTERIALAP2025-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219444-001AP

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
2026-09-14 22:38:342026-08A219444-001DEHYDRATED ALCOHOL99% (5ML)SOLUTION / INTRA-ARTERIALAP2025-06-2384e616aacf4f…
2026-08-18 06:07:402026-07A219444-001DEHYDRATED ALCOHOL99% (5ML)SOLUTION / INTRA-ARTERIALAP2025-06-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219444-001DEHYDRATED ALCOHOL99% (5ML)SOLUTION / INTRA-ARTERIALAP2025-06-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219444-001DEHYDRATED ALCOHOL99% (5ML)SOLUTION / INTRA-ARTERIALAP2025-06-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A219444-001DEHYDRATED ALCOHOL99% (5ML)SOLUTION / INTRA-ARTERIALAP2025-06-236a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219444-001DEHYDRATED ALCOHOL99% (5ML)SOLUTION / INTRA-ARTERIALAP2025-06-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219444-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A219444-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219444-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219444-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219444-001AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219444-001AP1a50c72e98297…

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
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
be10b253-d72a-4f57-aa27-94c70ae8aed3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51991-999-17Dehydrated Alcohol10 in 1 CARTONINJECTION, SOLUTION103
51991-999-75Dehydrated Alcohol5 mL in 1 VIAL, GLASSINJECTION, SOLUTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-999-17ML - Milliliter51991-9993ec26f67-38ee-420b-8045-81800885665312025-10-14
51991-999-75ML - Milliliter51991-999d0920220-96bd-4b5c-b133-b7966d1a7dc512025-10-14

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dehydrated AlcoholALCOHOLBreckenridge Pharmaceutical Incbe10b253-d72a-4f57-aa27-94c70ae8aed32026-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219444
application number: ANDA219444
ndc (product): 51991-999

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2048982ethanol 99 % in 5 ML InjectionPSNbe10b253-d72a-4f57-aa27-94c70ae8aed33
20489825 ML ethanol 0.99 ML/ML InjectionSCDbe10b253-d72a-4f57-aa27-94c70ae8aed33
2048982ethanol 99 % per 5 ML InjectionSYbe10b253-d72a-4f57-aa27-94c70ae8aed33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51991-999-175199109991710 VIAL, GLASS in 1 CARTON (51991-999-17) / 5 mL in 1 VIAL, GLASS (51991-999-75) 2025-09-23NoNoCurrent
51991-999-75519910999755 mL in 1 VIAL, GLASS5 mlHistorical