FDA.reportPublic FDA data

Hyosyne

Product NDC
54838-511
11-digit product format
548380511
Labeler code
54838
Product ID
54838-511_d46e4363-c0ff-415f-99e2-3b1c8c875194
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
ELIXIR
Route
ORAL
Labeler
Lannett Company, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1997-11-01
Substance
HYOSCYAMINE SULFATE
Active strength
.125 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYOSCYAMINE SULFATE.125 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF2R8V82B84
Rxcui1047881

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54838-511-80Hyosyne473 mL in 1 BOTTLE, PLASTICELIXIR47321

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54838-511-80ML - Milliliter54838-511e8defcde-2deb-4fc3-95fa-18c46843294a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hyoscyamine SulfateACTIVE INGREDIENTF2R8V82B84HYOSYNE (HYOSCYAMINE SULFATE) ELIXIR [SILARX PHARMACEUTICALS, INC]13
HyoscyamineACTIVE MOIETYPX44XO846XHYOSYNE (HYOSCYAMINE SULFATE) ELIXIR [SILARX PHARMACEUTICALS, INC]13
alcoholINACTIVE INGREDIENT3K9958V90MHYOSYNE (HYOSCYAMINE SULFATE) ELIXIR [SILARX PHARMACEUTICALS, INC]13
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLHYOSYNE (HYOSCYAMINE SULFATE) ELIXIR [SILARX PHARMACEUTICALS, INC]13
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYOSYNE (HYOSCYAMINE SULFATE) ELIXIR [SILARX PHARMACEUTICALS, INC]13
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYOSYNE (HYOSCYAMINE SULFATE) ELIXIR [SILARX PHARMACEUTICALS, INC]13
glycerinINACTIVE INGREDIENTPDC6A3C0OXHYOSYNE (HYOSCYAMINE SULFATE) ELIXIR [SILARX PHARMACEUTICALS, INC]13
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUHYOSYNE (HYOSCYAMINE SULFATE) ELIXIR [SILARX PHARMACEUTICALS, INC]13
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRHYOSYNE (HYOSCYAMINE SULFATE) ELIXIR [SILARX PHARMACEUTICALS, INC]13
sorbitolINACTIVE INGREDIENT506T60A25RHYOSYNE (HYOSCYAMINE SULFATE) ELIXIR [SILARX PHARMACEUTICALS, INC]13
sucroseINACTIVE INGREDIENTC151H8M554HYOSYNE (HYOSCYAMINE SULFATE) ELIXIR [SILARX PHARMACEUTICALS, INC]13
waterINACTIVE INGREDIENT059QF0KO0RHYOSYNE (HYOSCYAMINE SULFATE) ELIXIR [SILARX PHARMACEUTICALS, INC]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54838-511HYOSYNE (HYOSCYAMINE SULFATE) ELIXIR [LANNETT COMPANY, INC.]21Current NDC, Legacy NDC, 1 package rows20240517_a0e8f7d7-9316-4b78-acc8-17519b9b3165.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047881hyoscyamine sulfate 0.125 MG in 5 mL Oral SolutionPSNa0e8f7d7-9316-4b78-acc8-17519b9b316521
1047881hyoscyamine sulfate 0.025 MG/ML Oral SolutionSCDa0e8f7d7-9316-4b78-acc8-17519b9b316521
1047881hyoscyamine sulfate 0.125 MG per 5 ML Oral SolutionSYa0e8f7d7-9316-4b78-acc8-17519b9b316521
1047881hyoscyamine sulfate 0.125 MG in 5 mL Oral SolutionPSNd022cde6-90c7-48b5-8022-cf7b76f4da1912
1047881hyoscyamine sulfate 0.025 MG/ML Oral SolutionSCDd022cde6-90c7-48b5-8022-cf7b76f4da1912
1047881hyoscyamine sulfate 0.125 MG per 5 ML Oral SolutionSYd022cde6-90c7-48b5-8022-cf7b76f4da1912
1047881hyoscyamine sulfate 0.125 MG in 5 mL Oral SolutionPSN08ee0b24-a05b-451c-9d29-975570baed485
1047881hyoscyamine sulfate 0.025 MG/ML Oral SolutionSCD08ee0b24-a05b-451c-9d29-975570baed485
1047881hyoscyamine sulfate 0.125 MG per 5 ML Oral SolutionSY08ee0b24-a05b-451c-9d29-975570baed485

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54838-511-8054838051180473 mL in 1 BOTTLE, PLASTIC (54838-511-80) 473 ml1997-11-010000-00-00NoNoCurrent