HYOSCYAMINE SULFATE

Product NDC
54288-111
11-digit product format
542880111
Labeler code
54288
Product ID
54288-111_ba3bb8f4-5954-40a8-a072-2f75edb2c102
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYOSCYAMINE SULFATE
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
BPI Labs LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-10-18
Substance
HYOSCYAMINE SULFATE
Active strength
.5 mg/mL
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.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF2R8V82B84
Rxcui1047916

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54288-111-01HYOSCYAMINE SULFATE1 mL in 1 VIALINJECTION, SOLUTION110
54288-111-05HYOSCYAMINE SULFATE5 in 1 CARTONINJECTION, SOLUTION510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54288-111-01ML - Milliliter54288-1110017a589-20e0-4166-b053-9f0fd097047d12019-11-12
54288-111-05ML - Milliliter54288-1112073e957-68f3-4078-adc6-3256195cbe7812019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-111HYOSCYAMINE SULFATE INJECTION, SOLUTION [BPI LABS LLC]9Current NDC, Legacy NDC, 2 package rows20250213_6c0a1fef-c634-4ecf-9850-d188e6496b90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047916hyoscyamine sulfate 0.5 MG in 1 ML InjectionPSN6c0a1fef-c634-4ecf-9850-d188e6496b9010
10479161 ML hyoscyamine sulfate 0.5 MG/ML InjectionSCD6c0a1fef-c634-4ecf-9850-d188e6496b9010
1047916hyoscyamine sulfate 0.5 MG per 1 ML InjectionSY6c0a1fef-c634-4ecf-9850-d188e6496b9010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54288-111-01542880111011 mL in 1 VIAL1 mlHistorical
54288-111-05542880111055 VIAL in 1 CARTON (54288-111-05) / 1 mL in 1 VIAL (54288-111-01) 5 vial2019-10-180000-00-00NoNoCurrent