FDA.reportPublic FDA data

Phenohytro

Product NDC
17856-0123
11-digit product format
178560123
Labeler code
17856
Product ID
17856-0123_1ca4e527-6c78-41b9-8ecd-9a47607e1478
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine Hydrobromide
Dosage form
ELIXIR
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-03-14
Marketing end
0000-00-00
Substance
PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE
Active strength
16 mg/5mL; mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0123-12023-01-30C16284748780-1f386c649-fd19-0266-e053-dadaa90a7c1aPHENOHYTRO ® ELIXIR
17856-0123-22023-01-30C16284748780-1f386c649-fd19-0266-e053-dadaa90a7c1aPHENOHYTRO ® ELIXIR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0123-1Phenohytro5 mL in 1 CUP, UNIT-DOSEELIXIR52
17856-0123-1Phenohytro72 in 1 BOX, UNIT-DOSEELIXIR722
17856-0123-2Phenohytro10 mL in 1 CUP, UNIT-DOSEELIXIR102
17856-0123-2Phenohytro72 in 1 BOX, UNIT-DOSEELIXIR722

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0123PHENOHYTRO (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, AND SCOPOLAMINE HYDROBROMIDE) ELIXIR [ATLANTIC BIOLOGICALS CORP.]2Legacy NDC, 4 package rows20210113_d2c7febc-053e-4b22-9c99-af0e7fd9ce3f.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 SolutionPSNd2c7febc-053e-4b22-9c99-af0e7fd9ce3f2
2048017Phenohytro 16.2 MG / 0.1037 MG / 0.0194 MG / 0.0065 MG in 5 mL Oral SolutionPSNd2c7febc-053e-4b22-9c99-af0e7fd9ce3f2
2048017atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral Solution [Phenohytro]SBDd2c7febc-053e-4b22-9c99-af0e7fd9ce3f2
1046787atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral SolutionSCDd2c7febc-053e-4b22-9c99-af0e7fd9ce3f2
1046787atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG per 5 ML Oral SolutionSYd2c7febc-053e-4b22-9c99-af0e7fd9ce3f2
2048017Phenohytro (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine HBr 0.0065 MG) per 5 ML Oral SolutionSYd2c7febc-053e-4b22-9c99-af0e7fd9ce3f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17856-0123-11785601230172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0123-1) > 5 mL in 1 CUP, UNIT-DOSE2021-01-120000-00-00NoNoCurrent
17856-0123-21785601230272 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0123-2) > 10 mL in 1 CUP, UNIT-DOSE2021-01-120000-00-00NoNoCurrent