Orange Book product · Brand (NDA)
FIORICET W/ CODEINE
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
At a glance
Jul 30, 1992
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 30, 1992
34 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Strength
325MG;50MG;40MG;30MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 020232
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2022BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 215138 · HIKMA
- 2020BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 204649 · QUAGEN
- 2012BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 076560 · LGM PHARMA
- 2003BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 076528 · ABLE
- 2002BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 075929 · PHARMOBEDIENT
- 2001PHRENILIN WITH CAFFEINE AND CODEINEGeneric (ANDA)
ANDA 074911 · VALEANT
- 2001BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 075618 · HIKMA INTL PHARMS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
