Meperidine Injection

Brand(s)
Demerol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2015-06-29)
Oldest Current Product
1942-11-10
License(s)
NDA, ANDA
RxNORM
INJECTION\MEPERIDINE
FDAOB
INJECTION\INJECTION\MEPERIDINE HYDROCHLORIDE\rdfq
ORAL\SYRUP\MEPERIDINE HYDROCHLORIDE
ORAL\TABLET\MEPERIDINE HYDROCHLORIDE
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\MEPERIDINE HYDROCHLORIDE
INTRAMUSCULAR\INJECTION\MEPERIDINE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\MEPERIDINE
INTRAMUSCULAR\INJECTION\MEPERIDINE

product(s) by strength(s)

1 ml meperidine hydrochloride 100 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091256DemerolNDAHospira, Inc.1942-11-10MEPERIDINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONNDA021171b31d1308-28c3-43f4-e0a6-2f3ed76b8975

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416054ANDAWest-Ward Pharmaceuticals Corp.1975-01-22MEPERIDINE HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA080445e0e998da-f056-4fce-be8e-ed60cf3b461b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684751DemerolNDAPhysicians Total Care, Inc.2003-03-11MEPERIDINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004091256NDA02117153ddfe26-5a7e-4f39-8904-829a03538f63

1 ml meperidine hydrochloride 25 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416052ANDAWest-Ward Pharmaceuticals Corp.1975-01-22MEPERIDINE HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA080445e0e998da-f056-4fce-be8e-ed60cf3b461b

2 ml meperidine hydrochloride 50 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091255DemerolNDAHospira, Inc.1942-11-10MEPERIDINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONNDA021171b31d1308-28c3-43f4-e0a6-2f3ed76b8975

1.5 ml meperidine hydrochloride 50 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091254DemerolNDAHospira, Inc.1942-11-10MEPERIDINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONNDA021171b31d1308-28c3-43f4-e0a6-2f3ed76b8975

1 ml meperidine hydrochloride 50 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091253DemerolNDAHospira, Inc.1942-11-10MEPERIDINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONNDA021171b31d1308-28c3-43f4-e0a6-2f3ed76b8975

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416053ANDAWest-Ward Pharmaceuticals Corp.1975-01-22MEPERIDINE HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA080445e0e998da-f056-4fce-be8e-ed60cf3b461b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548683559ANDAPhysicians Total Care, Inc.2010-03-04MEPERIDINE HYDROCHLORIDEINTRAMUSCULARINJECTION100190160ANDA0804550084d5bc-17d5-4c58-a791-7ab3bb4590b7

0.5 ml meperidine hydrochloride 50 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091203DemerolNDAHospira, Inc.1942-11-10MEPERIDINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONNDA021171b31d1308-28c3-43f4-e0a6-2f3ed76b8975

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040163MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREETrueMALLINCKRODT CHEMICAL INC1997-05-12ANDA040163_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
2ANDA040305MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREETrueHOSPIRA INC1999-03-10ANDA040305_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
3ANDA073443MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREETrueWATSON LABORATORIES INC1992-03-17ANDA073443_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
4ANDA073444MEPERIDINE HYDROCHLORIDETrueWATSON LABORATORIES INC1992-03-17ANDA073444_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
5ANDA073445MEPERIDINE HYDROCHLORIDETrueWATSON LABORATORIES INC1992-03-17ANDA073445_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
6ANDA080364MEPERIDINE HYDROCHLORIDETruePARKE DAVIS DIV WARNER LAMBERT COANDA080364_001, ANDA080364_002, ANDA080364_003Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
7ANDA080385MEPERIDINE HYDROCHLORIDETrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA080385_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
8ANDA080386MEPERIDINE HYDROCHLORIDETrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA080386_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
9ANDA080387MEPERIDINE HYDROCHLORIDETrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA080387_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
10ANDA080388MEPERIDINE HYDROCHLORIDETrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA080388_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
11ANDA080389MEPERIDINE HYDROCHLORIDETrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA080389_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
12ANDA080445MEPERIDINE HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARLANDA080445_001, ANDA080445_002, ANDA080445_003, ANDA080445_004Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
13ANDA080455MEPERIDINE HYDROCHLORIDEHIKMA MAPLE LTDANDA080455_007, ANDA080455_008, ANDA080455_009, ANDA080455_010Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
14ANDA081002MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREEHIKMA MAPLE LTD1993-07-30ANDA081002_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
15ANDA081309MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREETrueINTERNATIONAL MEDICATION SYSTEM1993-08-30ANDA081309_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
16ANDA086332MEPERIDINE HYDROCHLORIDETrueINTERNATIONAL MEDICATION SYSTEMS LTDANDA086332_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
17ANDA088279MEPERIDINE HYDROCHLORIDETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE1984-06-15ANDA088279_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
18ANDA088280MEPERIDINE HYDROCHLORIDETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE1984-06-15ANDA088280_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
19ANDA088281MEPERIDINE HYDROCHLORIDETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE1984-06-15ANDA088281_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
20ANDA088282MEPERIDINE HYDROCHLORIDETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE1984-06-15ANDA088282_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
21ANDA088432MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREEHOSPIRA INC1984-08-16ANDA088432_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
22ANDA089781MEPERIDINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-03-31ANDA089781_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
23ANDA089782MEPERIDINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-03-31ANDA089782_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
24ANDA089783MEPERIDINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-03-31ANDA089783_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
25ANDA089784MEPERIDINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-03-31ANDA089784_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
26ANDA089785MEPERIDINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-03-31ANDA089785_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
27ANDA089786MEPERIDINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-03-31ANDA089786_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
28ANDA089787MEPERIDINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-03-31ANDA089787_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
29ANDA089788MEPERIDINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-03-31ANDA089788_001Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
30NDA005010DEMEROLSANOFI AVENTIS US LLCNDA005010_001, NDA005010_002, NDA005010_003, NDA005010_004, NDA005010_005, NDA005010_007, NDA005010_009Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge
Meperidine Oral Solution
31NDA021171DEMEROLHOSPIRA INCNDA021171_001, NDA021171_002, NDA021171_003, NDA021171_004Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Cartridge

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040163_001discontinuedMEPERIDINE HYDROCHLORIDE (10MG/ML)INJECTIONFalse1997-05-12MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
2ANDA040305_001discontinuedMEPERIDINE HYDROCHLORIDE (10MG/ML)INJECTIONFalse1999-03-10MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
3ANDA073443_001discontinuedMEPERIDINE HYDROCHLORIDE (10MG/ML)INJECTIONFalse1992-03-17MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
4ANDA073444_001discontinuedMEPERIDINE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1992-03-17MEPERIDINE HYDROCHLORIDE
5ANDA073445_001discontinuedMEPERIDINE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1992-03-17MEPERIDINE HYDROCHLORIDE
6ANDA080364_001discontinuedMEPERIDINE HYDROCHLORIDE (100MG/ML)INJECTIONFalseMEPERIDINE HYDROCHLORIDE
7ANDA080364_002discontinuedMEPERIDINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseMEPERIDINE HYDROCHLORIDE
8ANDA080364_003discontinuedMEPERIDINE HYDROCHLORIDE (75MG/ML)INJECTIONFalseMEPERIDINE HYDROCHLORIDE
9ANDA080385_001discontinuedMEPERIDINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseMEPERIDINE HYDROCHLORIDE
10ANDA080386_001discontinuedMEPERIDINE HYDROCHLORIDE (100MG/ML)INJECTIONFalseMEPERIDINE HYDROCHLORIDE
11ANDA080387_001discontinuedMEPERIDINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseMEPERIDINE HYDROCHLORIDE
12ANDA080388_001discontinuedMEPERIDINE HYDROCHLORIDE (25MG/ML)INJECTIONFalseMEPERIDINE HYDROCHLORIDE
13ANDA080389_001discontinuedMEPERIDINE HYDROCHLORIDE (75MG/ML)INJECTIONFalseMEPERIDINE HYDROCHLORIDE
14ANDA080445_001RXMEPERIDINE HYDROCHLORIDE (25MG/ML)INJECTIONFalseAPMEPERIDINE HYDROCHLORIDE
15ANDA080445_002RXMEPERIDINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseAPMEPERIDINE HYDROCHLORIDE
16ANDA080445_003RXMEPERIDINE HYDROCHLORIDE (75MG/ML)INJECTIONFalseAPMEPERIDINE HYDROCHLORIDE
17ANDA080445_004RXMEPERIDINE HYDROCHLORIDE (100MG/ML)INJECTIONFalseAPMEPERIDINE HYDROCHLORIDE
18ANDA080455_007RXMEPERIDINE HYDROCHLORIDE (25MG/ML)INJECTIONFalseAPMEPERIDINE HYDROCHLORIDE
19ANDA080455_008RXMEPERIDINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseAPMEPERIDINE HYDROCHLORIDE
20ANDA080455_009RXMEPERIDINE HYDROCHLORIDE (75MG/ML)INJECTIONFalseAPMEPERIDINE HYDROCHLORIDE
21ANDA080455_010RXMEPERIDINE HYDROCHLORIDE (100MG/ML)INJECTIONFalseAPMEPERIDINE HYDROCHLORIDE
22ANDA081002_001RXMEPERIDINE HYDROCHLORIDE (10MG/ML)INJECTIONFalseAP1993-07-30MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
23ANDA081309_001discontinuedMEPERIDINE HYDROCHLORIDE (10MG/ML)INJECTIONFalse1993-08-30MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
24ANDA086332_001discontinuedMEPERIDINE HYDROCHLORIDE (10MG/ML)INJECTIONFalseMEPERIDINE HYDROCHLORIDE
25ANDA088279_001discontinuedMEPERIDINE HYDROCHLORIDE (25MG/ML)INJECTIONFalse1984-06-15MEPERIDINE HYDROCHLORIDE
26ANDA088280_001discontinuedMEPERIDINE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1984-06-15MEPERIDINE HYDROCHLORIDE
27ANDA088281_001discontinuedMEPERIDINE HYDROCHLORIDE (75MG/ML)INJECTIONFalse1984-06-15MEPERIDINE HYDROCHLORIDE
28ANDA088282_001discontinuedMEPERIDINE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1984-06-15MEPERIDINE HYDROCHLORIDE
29ANDA088432_001RXMEPERIDINE HYDROCHLORIDE (10MG/ML)INJECTIONTrueAP1984-08-16MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
30ANDA089781_001discontinuedMEPERIDINE HYDROCHLORIDE (25MG/ML)INJECTIONFalse1989-03-31MEPERIDINE HYDROCHLORIDE
31ANDA089782_001discontinuedMEPERIDINE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1989-03-31MEPERIDINE HYDROCHLORIDE
32ANDA089783_001discontinuedMEPERIDINE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1989-03-31MEPERIDINE HYDROCHLORIDE
33ANDA089784_001discontinuedMEPERIDINE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1989-03-31MEPERIDINE HYDROCHLORIDE
34ANDA089785_001discontinuedMEPERIDINE HYDROCHLORIDE (75MG/ML)INJECTIONFalse1989-03-31MEPERIDINE HYDROCHLORIDE
35ANDA089786_001discontinuedMEPERIDINE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1989-03-31MEPERIDINE HYDROCHLORIDE
36ANDA089787_001discontinuedMEPERIDINE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1989-03-31MEPERIDINE HYDROCHLORIDE
37ANDA089788_001discontinuedMEPERIDINE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1989-03-31MEPERIDINE HYDROCHLORIDE
38NDA005010_001RXMEPERIDINE HYDROCHLORIDE (50MG)ORALTABLETTrueAADEMEROL
39NDA005010_002discontinuedMEPERIDINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseDEMEROL
40NDA005010_003discontinuedMEPERIDINE HYDROCHLORIDE (100MG/ML)INJECTIONFalseDEMEROL
41NDA005010_004RXMEPERIDINE HYDROCHLORIDE (100MG)ORALTABLETTrueAADEMEROL
42NDA005010_005discontinuedMEPERIDINE HYDROCHLORIDE (50MG/5ML)ORALSYRUPFalseDEMEROL
43NDA005010_007discontinuedMEPERIDINE HYDROCHLORIDE (25MG/ML)INJECTIONFalseDEMEROL
44NDA005010_009discontinuedMEPERIDINE HYDROCHLORIDE (75MG/ML)INJECTIONFalseDEMEROL
45NDA021171_001RXMEPERIDINE HYDROCHLORIDE (25MG/ML)INJECTIONTrueAPDEMEROL
46NDA021171_002RXMEPERIDINE HYDROCHLORIDE (50MG/ML)INJECTIONTrueAPDEMEROL
47NDA021171_003RXMEPERIDINE HYDROCHLORIDE (75MG/ML)INJECTIONTrueAPDEMEROL
48NDA021171_004RXMEPERIDINE HYDROCHLORIDE (100MG/ML)INJECTIONTrueAPDEMEROL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10084d5bc-17d5-4c58-a791-7ab3bb4590b7 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-05-061548683559
253ddfe26-5a7e-4f39-8904-829a03538f63 (view SPL)DemerolprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-12-283548684751, 548680616, 548683230, 548683610, 548685808Meperidine Injectable Solution
Meperidine Cartridge
3b31d1308-28c3-43f4-e0a6-2f3ed76b8975 (view SPL)DemerolprescriptionHuman PrescriptionHospira, Inc.2015-06-2912004091203, 004091253, 004091254, 004091255, 004091256, 004091176, 004091178, 004091179, 004091180, 004091181, 004091201Meperidine Injectable Solution
Meperidine Cartridge
4e0e998da-f056-4fce-be8e-ed60cf3b461b (view SPL)Meperidine Hydrochloride Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE2011-08-163006416052, 006416053, 006416054

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII