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Medicines · US (FDA)

FDA 2021

FDA

Hydrocodone Bitartrate

Approved 1 Mar 2021OralTablet, extended release

The FDA lists this product in 15 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: HYDROCODONE BITARTRATE 40MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

HYDROCODONE BITARTRATE 50MG · Capsule, extended releaseANDA206986-006 · Prescription
HYDROCODONE BITARTRATE 30MG · Capsule, extended releaseANDA206986-004 · Prescription
HYDROCODONE BITARTRATE 15MG · Capsule, extended releaseANDA206986-002 · Prescription
HYDROCODONE BITARTRATE 40MG · Capsule, extended releaseANDA206986-005 · Prescription
HYDROCODONE BITARTRATE 20MG · Capsule, extended releaseANDA206986-003 · Prescription
HYDROCODONE BITARTRATE 10MG · Capsule, extended releaseANDA206986-001 · Prescription
HYDROCODONE BITARTRATE 120MG · Tablet, extended releaseANDA208269-007 · Prescription
HYDROCODONE BITARTRATE 80MG · Tablet, extended releaseANDA208269-005 · Prescription
HYDROCODONE BITARTRATE 40MG · Tablet, extended releaseThis page

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

HYDROCODONE BITARTRATE 20MG · Tablet, extended releaseANDA208269-001 · Prescription

HYDROCODONE BITARTRATE 100MG · Tablet, extended releaseANDA208269-006 · Prescription

HYDROCODONE BITARTRATE 60MG · Tablet, extended releaseANDA208269-004 · Prescription

HYDROCODONE BITARTRATE 30MG · Tablet, extended releaseANDA208269-002 · Prescription

HYDROCODONE BITARTRATE 40MG · Capsule, extended releaseANDA206952-005 · Tentative approval

HYDROCODONE BITARTRATE 10MG · Capsule, extended releaseANDA206952-001 · Tentative approval

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA208269.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Hydrocodone Bitartrate
Route: Oral
Dosage form: Tablet, extended release
Applicant: Alvogen
Status: Prescription
FDA approval: 1 Mar 2021
Application: ANDA208269-003