MedPath

Natural Orange Flavor

Approved
Approval ID

c30129ac-4517-48b5-aafd-e65ec54b340e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 8, 2025

Manufacturers
FDA

Raritan Pharmaceuticals Inc

DUNS: 127602287

Products 1

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

Psyllium husk

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68163-571
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
Psyllium husk
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2025
FDA Product Classification

INGREDIENTS (4)

RAW SUGARInactive
Code: 8M707QY5GH
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PSYLLIUM HUSKActive
Quantity: 3.4 g in 12 g
Code: 0SHO53407G
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT

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Natural Orange Flavor - FDA Drug Approval Details