FDA.reportPublic FDA data

Hyoscyamine Sulfate

Product NDC
82804-965
Requested package NDC
82804-965-90
11-digit product format
828040965
Labeler code
82804
Product ID
82804-965_1f4b1ed7-bbba-4b2c-8139-b35cb428587d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-04-02
Substance
HYOSCYAMINE SULFATE
Active strength
.125 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hyoscyamine Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYOSCYAMINE SULFATE.125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F2R8V82B84Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1047905Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1f4b1ed7-bbba-4b2c-8139-b35cb428587dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-965-30Hyoscyamine Sulfate30 in 1 BOTTLETABLET301
82804-965-60Hyoscyamine Sulfate60 in 1 BOTTLETABLET601
82804-965-64Hyoscyamine Sulfate240 in 1 BOTTLETABLET2401
82804-965-72Hyoscyamine Sulfate120 in 1 BOTTLETABLET1201
82804-965-78Hyoscyamine Sulfate180 in 1 BOTTLETABLET1801
82804-965-90Hyoscyamine Sulfate90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-965-30EA - Each82804-965a3aadbff-83db-4613-848b-e21ce619632e12025-08-11
82804-965-60EA - Each82804-965eb245054-3173-4f60-b990-07b8cd76aeee12025-08-11
82804-965-64EA - Each82804-965f5a8ff60-4910-492b-b1f5-2b4a0a17fc7812025-08-11
82804-965-72EA - Each82804-9656bdb29f9-ced2-4c82-88cb-400b3bfef09212025-08-11
82804-965-78EA - Each82804-965d4bdb261-aaf8-48e7-b6d4-9eb92dc7b7cc12025-08-11
82804-965-90EA - Each82804-965a22a13c6-59f9-442a-b5e9-a9c48c1e79aa12025-08-11

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hyoscyamine SulfateHYOSCYAMINE SULFATEProficient Rx LP1f4b1ed7-bbba-4b2c-8139-b35cb428587d2025-06-01Warnings, Adverse reactionsExact identifier
ndc (package): 82804-965-90
ndc (product): 82804-965
ndc11 (package): 82804096590

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047905hyoscyamine sulfate 0.125 MG Oral TabletPSN1f4b1ed7-bbba-4b2c-8139-b35cb428587d1
1047905hyoscyamine sulfate 0.125 MG Oral TabletSCD1f4b1ed7-bbba-4b2c-8139-b35cb428587d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-965-908280409659090 TABLET in 1 BOTTLE (82804-965-90) 90 tablet2025-06-25NoNoCurrent