MedPath
FDA Approval

Xodol

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
September 26, 2012
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Acetaminophen(300 mg in 1 1)
Hydrocodone(5 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

PSS World Medical, Inc.

101822862

Manufacturing Establishments6

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Dispensing Solutions, Inc.

Rebel Distributors Corp

PSS World Medical, Inc.

066070785

STAT RX USA LLC

Rebel Distributors Corp

PSS World Medical, Inc.

786036330

SCRIPT PAK

Rebel Distributors Corp

PSS World Medical, Inc.

964420108

PSS World Medical, Inc.

Rebel Distributors Corp

PSS World Medical, Inc.

791528623

Keltman Pharmaceuticals, Inc.

Rebel Distributors Corp

PSS World Medical, Inc.

362861077

Rebel Distirbutors Corp.

Rebel Distributors Corp

PSS World Medical, Inc.

118802834

Products2

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

Xodol

Product Details

NDC Product Code
42254-291
Application Number
ANDA040658
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 20, 2010
Code: 362O9ITL9DClass: ACTIBQuantity: 300 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: NO70W886KKClass: ACTIBQuantity: 5 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONESInactive
Code: FZ989GH94EClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT

Xodol

Product Details

NDC Product Code
42254-301
Application Number
ANDA040556
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 20, 2010
Code: 362O9ITL9DClass: ACTIBQuantity: 300 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
Code: NO70W886KKClass: ACTIBQuantity: 10 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POVIDONESInactive
Code: FZ989GH94EClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
© Copyright 2025. All Rights Reserved by MedPath