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QUADRAPAX

QUADRAPAX ELIXIR

Approved
Approval ID

6243f28a-e7ed-4571-beb3-2562c5e033c7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 13, 2011

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-970
Product Classification
G
Generic Name
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateMay 19, 2011
FDA Product Classification

INGREDIENTS (10)

Atropine SulfateActive
Quantity: 0.0194 mg in 5 mL
Code: 03J5ZE7KA5
Classification: ACTIB
PhenobarbitalActive
Quantity: 16.2 mg in 5 mL
Code: YQE403BP4D
Classification: ACTIB
Scopolamine HydrobromideActive
Quantity: 0.0065 mg in 5 mL
Code: 451IFR0GXB
Classification: ACTIB
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
SorbitolInactive
Code: 506T60A25R
Classification: IACT
Saccharin SodiumInactive
Code: SB8ZUX40TY
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
Hyoscyamine SulfateActive
Quantity: 0.1037 mg in 5 mL
Code: F2R8V82B84
Classification: ACTIB

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QUADRAPAX - FDA Drug Approval Details