Orange Book product · Brand (NDA)
DEMEROL
MEPERIDINE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
MEPERIDINE HYDROCHLORIDE
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 005010
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- —DEMEROLBrand (NDA)
NDA 021171 · HOSPIRA
- 2009MEPERIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040893 · GENUS
- 2002MEPERIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040446 · SUN PHARM INDS INC
- 2000MEPERIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040352 · SPECGX LLC
- 1999MEPERIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040318 · DURAMED PHARMS BARR
- 1999MEPERIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040331 · EPIC PHARMA LLC
- 1999MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREEGeneric (ANDA)
ANDA 040305 · HOSPIRA
- 1998MEPERIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040191 · STRIDES PHARMA INTL
- 1997MEPERIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040186 · WATSON LABS
- 1997MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREEGeneric (ANDA)
ANDA 040163 · SPECGX LLC
- 1997MEPERIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040110 · HIKMA
- 1993MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREEGeneric (ANDA)
ANDA 081309 · INTL MEDICATION
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.
