FDA.reportPublic FDA data

Hyoscyamine Sulfate

Product NDC
82804-965
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 Identifiers#

Field, Values table
FieldValues
UniiF2R8V82B84
Rxcui1047905

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

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
82804-965-308280409653030 TABLET in 1 BOTTLE (82804-965-30) 30 tablet2025-06-25NoNoHistorical
82804-965-608280409656060 TABLET in 1 BOTTLE (82804-965-60) 60 tablet2025-06-25NoNoHistorical
82804-965-6482804096564240 TABLET in 1 BOTTLE (82804-965-64) 240 tablet2025-06-25NoNoHistorical
82804-965-7282804096572120 TABLET in 1 BOTTLE (82804-965-72) 120 tablet2025-06-25NoNoHistorical
82804-965-7882804096578180 TABLET in 1 BOTTLE (82804-965-78) 180 tablet2025-06-25NoNoHistorical
82804-965-908280409659090 TABLET in 1 BOTTLE (82804-965-90) 90 tablet2025-06-25NoNoHistorical