FDA.reportPublic FDA data

QUADRAPAX

Product NDC
21695-970
11-digit product format
216950970
Labeler code
21695
Product ID
21695-970_6243f28a-e7ed-4571-beb3-2562c5e033c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Dosage form
ELIXIR
Route
ORAL
Labeler
Rebel Distributors Corp
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-05-06
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
E
Listing certified through
2017-12-31
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
21695-970-162019-09-24C16284748780-1934fe258-47b5-48b1-e053-8cdaa90a720aQUADRAPAX ELIXIR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-970-16QUADRAPAX473 mL in 1 BOTTLEELIXIR4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-970-16ML - Milliliter21695-970ea5d8133-66ca-46a4-b00c-61fff85bc62312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Atropine SulfateACTIVE INGREDIENT03J5ZE7KA5QUADRAPAX (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [REBEL DISTRIBUTORS CORP]1
Hyoscyamine SulfateACTIVE INGREDIENTF2R8V82B84QUADRAPAX (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [REBEL DISTRIBUTORS CORP]1
PhenobarbitalACTIVE INGREDIENTYQE403BP4DQUADRAPAX (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [REBEL DISTRIBUTORS CORP]1
Scopolamine HydrobromideACTIVE INGREDIENT451IFR0GXBQUADRAPAX (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [REBEL DISTRIBUTORS CORP]1
AtropineACTIVE MOIETY7C0697DR9IQUADRAPAX (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [REBEL DISTRIBUTORS CORP]1
HyoscyamineACTIVE MOIETYPX44XO846XQUADRAPAX (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [REBEL DISTRIBUTORS CORP]1
PhenobarbitalACTIVE MOIETYYQE403BP4DQUADRAPAX (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [REBEL DISTRIBUTORS CORP]1
ScopolamineACTIVE MOIETYDL48G20X8XQUADRAPAX (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [REBEL DISTRIBUTORS CORP]1
AlcoholINACTIVE INGREDIENT3K9958V90MQUADRAPAX (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [REBEL DISTRIBUTORS CORP]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXQUADRAPAX (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [REBEL DISTRIBUTORS CORP]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYQUADRAPAX (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [REBEL DISTRIBUTORS CORP]1
SorbitolINACTIVE INGREDIENT506T60A25RQUADRAPAX (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [REBEL DISTRIBUTORS CORP]1
SucroseINACTIVE INGREDIENTC151H8M554QUADRAPAX (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [REBEL DISTRIBUTORS CORP]1
WaterINACTIVE INGREDIENT059QF0KO0RQUADRAPAX (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-970QUADRAPAX (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20111118_6243f28a-e7ed-4571-beb3-2562c5e033c7.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 SolutionPSN6243f28a-e7ed-4571-beb3-2562c5e033c71
1046787atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral SolutionSCD6243f28a-e7ed-4571-beb3-2562c5e033c71
1046787atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG per 5 ML Oral SolutionSY6243f28a-e7ed-4571-beb3-2562c5e033c71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-970-1621695097016473 mL in 1 BOTTLE473 mlHistorical