FDA.reportPublic FDA data

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide

Product NDC
50742-666
11-digit product format
507420666
Labeler code
50742
Product ID
50742-666_5e9a2654-23e8-43de-a8fa-d981d7f13e40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Dosage form
ELIXIR
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-08-01
Substance
ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE
Active strength
.0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE SULFATE.0194 mg/5mL
HYOSCYAMINE SULFATE.1037 mg/5mL
PHENOBARBITAL16.2 mg/5mL
SCOPOLAMINE HYDROBROMIDE.0065 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYQE403BP4D, 03J5ZE7KA5, F2R8V82B84, 451IFR0GXB
Rxcui1046787

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
fe8ea78e-e1a4-44bf-a6b2-42eed76976bbProduct name520250218
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
e3e67a66-d325-4d80-8f9d-059e736d7b00Product name120230912
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50742-666-04Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide118 mL in 1 BOTTLEELIXIR1182
50742-666-16Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide473 mL in 1 BOTTLEELIXIR4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-666-04ML - Milliliter50742-66601904ebc-8b1a-41cf-b130-86e61043c53412022-01-06
50742-666-16ML - Milliliter50742-666f538a322-3376-4b91-985b-ec10b6d760aa12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-666PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE ELIXIR [INGENUS PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 2 package rows20230120_33bf2df5-bc53-4d57-a9e7-41f3fc0a03f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046787PHENobarbital 16.2 MG / hyoscyamine sulfate 0.1037 MG / atropine sulfate 0.0194 MG / scopolamine HBr 0.0065 MG in 5 mL Oral SolutionPSN33bf2df5-bc53-4d57-a9e7-41f3fc0a03f02
1046787atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral SolutionSCD33bf2df5-bc53-4d57-a9e7-41f3fc0a03f02
1046787atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG per 5 ML Oral SolutionSY33bf2df5-bc53-4d57-a9e7-41f3fc0a03f02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-666-0450742066604118 mL in 1 BOTTLE (50742-666-04) 118 ml2021-08-010000-00-00NoNoCurrent
50742-666-1650742066616473 mL in 1 BOTTLE (50742-666-16) 473 ml2021-08-010000-00-00NoNoCurrent