Meperidine Injectable Solution

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, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTABLE SOLUTION\MEPERIDINE
FDAOB
INJECTION\INJECTION\MEPERIDINE HYDROCHLORIDE\rdfq
ORAL\SYRUP\MEPERIDINE HYDROCHLORIDE
ORAL\TABLET\MEPERIDINE HYDROCHLORIDE
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\MEPERIDINE HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION\MEPERIDINE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\MEPERIDINE
INTRAVENOUS\INJECTION, SOLUTION\MEPERIDINE

product(s) by strength(s)

meperidine hydrochloride 10 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330042UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2012-01-23, 2013-11-14, 2014-08-13MEPERIDINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION113af047-dbe4-4e05-a114-9fec85f3ee8a, 273dcb3a-286a-428e-95d3-522524915f5f, 69d7cc96-cf56-472b-8db4-a8a0038c1415

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004096030ANDAHospira, Inc.1984-08-16MEPERIDINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA0884327df4e964-2a34-4f38-4d8b-62bb637323c7

meperidine hydrochloride 100 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091201DemerolNDAHospira, Inc.1942-11-10MEPERIDINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONNDA021171b31d1308-28c3-43f4-e0a6-2f3ed76b8975

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548683610DemerolNDAPhysicians Total Care, Inc.1995-07-052011-06-30MEPERIDINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004091201NDA02117153ddfe26-5a7e-4f39-8904-829a03538f63

meperidine hydrochloride 50 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091181DemerolNDAHospira, Inc.1942-11-10MEPERIDINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONNDA021171b31d1308-28c3-43f4-e0a6-2f3ed76b8975

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548680616DemerolNDAPhysicians Total Care, Inc.2000-07-132011-06-30MEPERIDINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004091181NDA02117153ddfe26-5a7e-4f39-8904-829a03538f63
2548683230DemerolNDAPhysicians Total Care, Inc.1994-04-11MEPERIDINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004091253NDA02117153ddfe26-5a7e-4f39-8904-829a03538f63

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040163MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREETrueMALLINCKRODT CHEMICAL INC1997-05-12ANDA040163_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
2ANDA040305MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREETrueHOSPIRA INC1999-03-10ANDA040305_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
3ANDA073443MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREETrueWATSON LABORATORIES INC1992-03-17ANDA073443_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
4ANDA073444MEPERIDINE HYDROCHLORIDETrueWATSON LABORATORIES INC1992-03-17ANDA073444_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
5ANDA073445MEPERIDINE HYDROCHLORIDETrueWATSON LABORATORIES INC1992-03-17ANDA073445_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
6ANDA080364MEPERIDINE HYDROCHLORIDETruePARKE DAVIS DIV WARNER LAMBERT COANDA080364_001, ANDA080364_002, ANDA080364_003Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
7ANDA080385MEPERIDINE HYDROCHLORIDETrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA080385_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
8ANDA080386MEPERIDINE HYDROCHLORIDETrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA080386_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
9ANDA080387MEPERIDINE HYDROCHLORIDETrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA080387_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
10ANDA080388MEPERIDINE HYDROCHLORIDETrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA080388_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
11ANDA080389MEPERIDINE HYDROCHLORIDETrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA080389_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
12ANDA080445MEPERIDINE HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARLANDA080445_001, ANDA080445_002, ANDA080445_003, ANDA080445_004Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
13ANDA080455MEPERIDINE HYDROCHLORIDEHIKMA MAPLE LTDANDA080455_007, ANDA080455_008, ANDA080455_009, ANDA080455_010Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
14ANDA081002MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREEHIKMA MAPLE LTD1993-07-30ANDA081002_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
15ANDA081309MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREETrueINTERNATIONAL MEDICATION SYSTEM1993-08-30ANDA081309_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
16ANDA086332MEPERIDINE HYDROCHLORIDETrueINTERNATIONAL MEDICATION SYSTEMS LTDANDA086332_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
17ANDA088279MEPERIDINE HYDROCHLORIDETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE1984-06-15ANDA088279_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
18ANDA088280MEPERIDINE HYDROCHLORIDETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE1984-06-15ANDA088280_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
19ANDA088281MEPERIDINE HYDROCHLORIDETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE1984-06-15ANDA088281_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
20ANDA088282MEPERIDINE HYDROCHLORIDETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE1984-06-15ANDA088282_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
21ANDA088432MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREEHOSPIRA INC1984-08-16ANDA088432_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
22ANDA089781MEPERIDINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-03-31ANDA089781_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
23ANDA089782MEPERIDINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-03-31ANDA089782_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
24ANDA089783MEPERIDINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-03-31ANDA089783_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
25ANDA089784MEPERIDINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-03-31ANDA089784_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
26ANDA089785MEPERIDINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-03-31ANDA089785_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
27ANDA089786MEPERIDINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-03-31ANDA089786_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
28ANDA089787MEPERIDINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-03-31ANDA089787_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
29ANDA089788MEPERIDINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-03-31ANDA089788_001Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
30NDA005010DEMEROLSANOFI AVENTIS US LLCNDA005010_001, NDA005010_002, NDA005010_003, NDA005010_004, NDA005010_005, NDA005010_007, NDA005010_009Meperidine Oral Tablet
Meperidine Injection
Meperidine Cartridge
Meperidine Oral Solution
31NDA021171DEMEROLHOSPIRA INCNDA021171_001, NDA021171_002, NDA021171_003, NDA021171_004Meperidine Oral Tablet
Meperidine Injection
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
1113af047-dbe4-4e05-a114-9fec85f3ee8a (view SPL)Meperidine HCl 10 mg/mL in 0.9% Sodium Chloride 30 mL PCA VialprescriptionHuman PrescriptionCantrell Drug Companymanufacture2014-08-131525330042
2273dcb3a-286a-428e-95d3-522524915f5f (view SPL)Meperidine HCl 10 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNetprescriptionHuman PrescriptionCantrell Drug Companymanufacture2014-04-301525330042
353ddfe26-5a7e-4f39-8904-829a03538f63 (view SPL)DemerolprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-12-283548680616, 548683230, 548683610, 548684751, 548685808Meperidine Injection
Meperidine Cartridge
469d7cc96-cf56-472b-8db4-a8a0038c1415 (view SPL)Meperidine HCl 10 mg/mL in 0.9% Sodium Chloride 60 mL BagprescriptionHuman PrescriptionCantrell Drug Companymanufacture2014-04-092525330042
57df4e964-2a34-4f38-4d8b-62bb637323c7 (view SPL)MEPERIDINEHydrochlorideprescriptionHuman PrescriptionHospira, Inc.2012-06-0410004096030
6b31d1308-28c3-43f4-e0a6-2f3ed76b8975 (view SPL)DemerolprescriptionHuman PrescriptionHospira, Inc.2015-06-2912004091181, 004091201, 004091176, 004091178, 004091179, 004091180, 004091203, 004091253, 004091254, 004091255, 004091256Meperidine Injection
Meperidine Cartridge

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