FDA.reportPublic FDA data

Galantamine Hydrobromide

Product NDC
0054-0137
11-digit product format
000540137
Labeler code
0054
Product ID
0054-0137_b2bf3efc-7521-4ff7-b77c-6e312e34b3c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Galantamine Hydrobromide
Dosage form
SOLUTION
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA078185
Marketing category
ANDA
Marketing start
2009-08-14
Substance
GALANTAMINE HYDROBROMIDE
Active strength
4 mg/mL
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
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
A078185-001GALANTAMINE HYDROBROMIDEGALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-303f01610625f2…
2019-09-15 20:21 UTC2019-09A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078185-001GALANTAMINE HYDROBROMIDE4MG/MLSOLUTION / ORALRS2009-01-30cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Galantamine Hydrobromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GALANTAMINE HYDROBROMIDE4 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MJ4PTD2VVWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
860901Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d5b0e225-e94d-4324-afb2-b6e51c949dd0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f780b87f-43f1-2d63-f0ea-2c214058238eProduct name220160831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-0137-49Galantamine Hydrobromide100 mL in 1 BOTTLESOLUTION10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0137-49ML - Milliliter0054-0137fef1a217-7ea1-4cde-8d97-ddd582fef4e012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GALANTAMINE HYDROBROMIDEACTIVE INGREDIENTMJ4PTD2VVWGALANTAMINE HYDROBROMIDE SOLUTION [ROXANE LABORATORIES, INC]4
GALANTAMINEACTIVE MOIETY0D3Q044KCAGALANTAMINE HYDROBROMIDE SOLUTION [ROXANE LABORATORIES, INC]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGALANTAMINE HYDROBROMIDE SOLUTION [ROXANE LABORATORIES, INC]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGALANTAMINE HYDROBROMIDE SOLUTION [ROXANE LABORATORIES, INC]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGALANTAMINE HYDROBROMIDE SOLUTION [ROXANE LABORATORIES, INC]4
WATERINACTIVE INGREDIENT059QF0KO0RGALANTAMINE HYDROBROMIDE SOLUTION [ROXANE LABORATORIES, INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0137GALANTAMINE HYDROBROMIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]11Current NDC, Legacy NDC, 1 package rows20240110_d5b0e225-e94d-4324-afb2-b6e51c949dd0.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Galantamine HydrobromideGALANTAMINE HYDROBROMIDEHikma Pharmaceuticals USA Inc.d5b0e225-e94d-4324-afb2-b6e51c949dd02023-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078185
application number: ANDA078185
ndc (product): 0054-0137

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860901galantamine HBr 4 MG in 1 mL Oral SolutionPSNd5b0e225-e94d-4324-afb2-b6e51c949dd011
860901galantamine hydrobromide 4 MG/ML Oral SolutionSCDd5b0e225-e94d-4324-afb2-b6e51c949dd011
860901galantamine HBr 4 MG per 1 ML Oral SolutionSYd5b0e225-e94d-4324-afb2-b6e51c949dd011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0137-4900054013749100 mL in 1 BOTTLE (0054-0137-49) 100 ml2009-08-140000-00-00NoNoCurrent