FDA.reportPublic FDA data

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide

Product NDC
50742-667
11-digit product format
507420667
Labeler code
50742
Product ID
50742-667_3796f3d7-7e45-4a49-aaa2-7363c197b2f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide
Dosage form
TABLET
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/1; mg/1; mg/1; mg/1
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 and Scopolamine Hydrobromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE SULFATE.0194 mg/1
HYOSCYAMINE SULFATE.1037 mg/1
PHENOBARBITAL16.2 mg/1
SCOPOLAMINE HYDROBROMIDE.0065 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii03J5ZE7KA5, F2R8V82B84, YQE403BP4D, 451IFR0GXB
Rxcui1046815

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
50742-667-01Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide100 in 1 BOTTLE, PLASTICTABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-667-01EA - Each50742-667d7f75b6b-4637-4939-a52e-76087ddcdc4612022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-667PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE AND SCOPOLAMINE HYDROBROMIDE TABLET [INGENUS PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 1 package rows20230120_0dd71f55-e009-48dd-809d-5f651f7521de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046815atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / PHENobarbital 16.2 MG / scopolamine HBr 0.0065 MG Oral TabletPSN0dd71f55-e009-48dd-809d-5f651f7521de2
1046815atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral TabletSCD0dd71f55-e009-48dd-809d-5f651f7521de2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-667-0150742066701100 TABLET in 1 BOTTLE, PLASTIC (50742-667-01) 100 tablet2021-08-010000-00-00NoNoCurrent