FDA.reportPublic FDA data

DEHYDRATED ALCOHOL

Product NDC
16729-710
Requested package NDC
16729-710-53
11-digit product format
167290710
Labeler code
16729
Product ID
16729-710_52566f68-6e40-af49-e063-6394a90a01ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALCOHOL
Dosage form
INJECTION, SOLUTION
Route
PERCUTANEOUS
Labeler
Accord Healthcare, Inc.
Application
ANDA217845
Marketing category
ANDA
Marketing start
2025-06-25
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
A217845-001DEHYDRATED 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
A217845-001AP

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 22:38:342026-08A217845-001DEHYDRATED ALCOHOL99% (5ML)SOLUTION / INTRA-ARTERIALAP2025-06-2384e616aacf4f…
2026-08-18 06:07:402026-07A217845-001DEHYDRATED ALCOHOL99% (5ML)SOLUTION / INTRA-ARTERIALAP2025-06-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217845-001DEHYDRATED ALCOHOL99% (5ML)SOLUTION / INTRA-ARTERIALAP2025-06-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217845-001DEHYDRATED ALCOHOL99% (5ML)SOLUTION / INTRA-ARTERIALAP2025-06-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A217845-001DEHYDRATED ALCOHOL99% (5ML)SOLUTION / INTRA-ARTERIALAP2025-06-236a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217845-001DEHYDRATED 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 22:38:342026-08A217845-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A217845-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217845-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217845-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217845-001AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217845-001AP1a50c72e98297…

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
07fa92f7-d752-42e3-a572-b552461c4389Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-710-31DEHYDRATED ALCOHOL5 mL in 1 VIALINJECTION, SOLUTION55
16729-710-45DEHYDRATED ALCOHOL10 in 1 CARTONINJECTION, SOLUTION105
16729-710-53DEHYDRATED ALCOHOL5 in 1 CARTONINJECTION, SOLUTION55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-710-31ML - Milliliter16729-710cd125ca5-3af5-4f99-b83c-5ad571b9a87b12026-01-08
16729-710-45ML - Milliliter16729-710a5a6cc05-04c0-4c2c-b6ab-9766bb8c794d12025-07-08
16729-710-53ML - Milliliter16729-71070c67770-184a-48ac-baa7-1cf0f765aa8412026-05-22

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 ALCOHOLALCOHOLAccord Healthcare, Inc.07fa92f7-d752-42e3-a572-b552461c43892026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217845
application number: ANDA217845
ndc (package): 16729-710-53
ndc (product): 16729-710
ndc11 (package): 16729071053

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2048982ethanol 99 % in 5 ML InjectionPSN07fa92f7-d752-42e3-a572-b552461c43895
20489825 ML ethanol 0.99 ML/ML InjectionSCD07fa92f7-d752-42e3-a572-b552461c43895
2048982ethanol 99 % per 5 ML InjectionSY07fa92f7-d752-42e3-a572-b552461c43895

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16729-710-53167290710535 VIAL in 1 CARTON (16729-710-53) / 5 mL in 1 VIAL (16729-710-31) 5 vial2026-04-16NoNoCurrent