Dehydrated Alcohol

Product NDC
62250-105
Requested package NDC
62250-105-10
11-digit product format
622500105
Labeler code
62250
Product ID
62250-105_d2d30cbc-6af1-a8a2-e053-2a95a90a682e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alcohol
Dosage form
INJECTION, SOLUTION
Route
PERCUTANEOUS
Labeler
Belcher Pharmaceuticals, LLC
Application
NDA207987
Marketing category
NDA
Marketing start
2018-07-02
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
1 mL/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage62250-10562250-105-10IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N207987-001ABLYSINOLDEHYDRATED ALCOHOL99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRA-ARTERIALRLD2018-06-21
N207987-002ABLYSINOLDEHYDRATED ALCOHOL99% (5ML)SOLUTION / INTRA-ARTERIALAPRLD, RS2018-06-21

Therapeutic equivalence codes#

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

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

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N207987-001ABLYSINOL99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRA-ARTERIALRLD2018-06-21caaa826d4ba7…
2026-08-18 06:07:402026-07N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALAPRLD, RS2018-06-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N207987-001ABLYSINOL99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRA-ARTERIALRLD2018-06-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALAPRLD, RS2018-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207987-001ABLYSINOL99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRA-ARTERIALRLD2018-06-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALAPRLD, RS2018-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N207987-001ABLYSINOL99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRA-ARTERIALRLD2018-06-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALAPRLD, RS2018-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207987-001ABLYSINOL99% (1ML)SOLUTION / INTRA-ARTERIALRLD2018-06-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALRLD, RS2018-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207987-001ABLYSINOL99% (1ML)SOLUTION / INTRA-ARTERIALRLD2018-06-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALRLD, RS2018-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207987-001ABLYSINOL99% (1ML)SOLUTION / INTRA-ARTERIALRLD2018-06-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALRLD, RS2018-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207987-001ABLYSINOL99% (1ML)SOLUTION / INTRA-ARTERIALRLD2018-06-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALRLD, RS2018-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207987-001ABLYSINOL99% (1ML)SOLUTION / INTRA-ARTERIALRLD2018-06-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALRLD, RS2018-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207987-001ABLYSINOL99% (1ML)SOLUTION / INTRA-ARTERIALRLD2018-06-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALRLD, RS2018-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207987-001ABLYSINOL99% (1ML)SOLUTION / INTRA-ARTERIALRLD2018-06-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALRLD, RS2018-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207987-001ABLYSINOL99% (1ML)SOLUTION / INTRA-ARTERIALRLD2018-06-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALRLD, RS2018-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207987-001ABLYSINOL99% (1ML)SOLUTION / INTRA-ARTERIALRLD2018-06-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALRLD, RS2018-06-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207987-001ABLYSINOL99% (1ML)SOLUTION / INTRA-ARTERIALRLD2018-06-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALRLD, RS2018-06-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N207987-001ABLYSINOL99% (1ML)SOLUTION / INTRA-ARTERIALRLD2018-06-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALRLD, RS2018-06-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207987-001ABLYSINOL99% (1ML)SOLUTION / INTRA-ARTERIALRLD2018-06-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALRLD, RS2018-06-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N207987-001ABLYSINOL99% (1ML)SOLUTION / INTRA-ARTERIALRLD2018-06-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALRLD, RS2018-06-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N207987-001ABLYSINOL99% (1ML)SOLUTION / INTRA-ARTERIALRLD2018-06-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALRLD, RS2018-06-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N207987-001ABLYSINOL99% (1ML)SOLUTION / INTRA-ARTERIALRLD2018-06-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALRLD, RS2018-06-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N207987-001ABLYSINOL99% (1ML)SOLUTION / INTRA-ARTERIALRLD2018-06-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N207987-002ABLYSINOL99% (5ML)SOLUTION / INTRA-ARTERIALRLD, RS2018-06-21bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N207987-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N207987-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207987-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N207987-002AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N207987-002AP1a50c72e98297…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207987-001ODE-1922025-06-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207987-002ODE-1922025-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N207987-001ODE-1922025-06-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207987-002ODE-1922025-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207987-001ODE-1922025-06-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207987-002ODE-1922025-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207987-001ODE-1922025-06-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207987-002ODE-1922025-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207987-001ODE-1922025-06-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207987-002ODE-1922025-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207987-001ODE-1922025-06-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207987-002ODE-1922025-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207987-001ODE-1922025-06-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207987-002ODE-1922025-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207987-001ODE-1922025-06-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207987-002ODE-1922025-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207987-001ODE-1922025-06-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N207987-002ODE-1922025-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207987-001ODE-1922025-06-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207987-002ODE-1922025-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207987-001ODE-1922025-06-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207987-002ODE-1922025-06-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207987-001ODE-1922025-06-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207987-002ODE-1922025-06-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N207987-001ODE-1922025-06-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05N207987-002ODE-1922025-06-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207987-001ODE-1922025-06-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207987-002ODE-1922025-06-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N207987-001ODE-1922025-06-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N207987-002ODE-1922025-06-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N207987-001ODE-1922025-06-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N207987-002ODE-1922025-06-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N207987-001ODE-1922025-06-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207987-002ODE-1922025-06-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N207987-001ODE-1922025-06-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N207987-002ODE-1922025-06-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N207987-001ODE-1922025-06-21782e0a99824c…
2021-12-28 21:50 UTC2021-12N207987-002ODE-1922025-06-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N207987-001ODE-1922025-06-2187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N207987-002ODE-1922025-06-2187673890dc5c…

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62250-105-01Dehydrated Alcohol1 mL in 1 AMPULEINJECTION, SOLUTION16
62250-105-02Dehydrated Alcohol5 mL in 1 AMPULEINJECTION, SOLUTION56
62250-105-10Dehydrated Alcohol10 in 1 CARTONINJECTION, SOLUTION106
62250-105-15Dehydrated Alcohol10 in 1 CARTONINJECTION, SOLUTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62250-105DEHYDRATED ALCOHOL (ALCOHOL) INJECTION, SOLUTION [BELCHER PHARMACEUTICALS, LLC]6Legacy NDC, 4 package rows20211212_379e7c93-14a7-42d0-920f-a6b5eca34b99.zip

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dehydrated AlcoholALCOHOLBPI Labs, LLC314b1dab-8f4f-49ae-a105-f974842818b82026-01-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 207987
application number: NDA207987
Dehydrated AlcoholALCOHOLAjenat Pharmaceuticals LLC636d6421-cadf-42b3-a431-ba40c06e36d22025-12-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 207987
application number: NDA207987

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2048979ethanol 99 % in 1 ML InjectionPSN379e7c93-14a7-42d0-920f-a6b5eca34b996
2048982ethanol 99 % in 5 ML InjectionPSN379e7c93-14a7-42d0-920f-a6b5eca34b996
20489791 ML ethanol 0.99 ML/ML InjectionSCD379e7c93-14a7-42d0-920f-a6b5eca34b996
20489825 ML ethanol 0.99 ML/ML InjectionSCD379e7c93-14a7-42d0-920f-a6b5eca34b996
2048979ethanol 99 % per 1 ML InjectionSY379e7c93-14a7-42d0-920f-a6b5eca34b996
2048982ethanol 99 % per 5 ML InjectionSY379e7c93-14a7-42d0-920f-a6b5eca34b996

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62250-105-106225001051010 AMPULE in 1 CARTON (62250-105-10) > 1 mL in 1 AMPULE (62250-105-01) 10 ampule2018-07-020000-00-00NoNoCurrent