Diphenhydramine Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
West-Ward Pharmaceuticals Corp. (2011-06-13)
Oldest Current Product
1972-11-27
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\DIPHENHYDRAMINE
FDAOB
INJECTION\INJECTION\DIPHENHYDRAMINE HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\DIPHENHYDRAMINE HYDROCHLORIDE
INTRAMUSCULAR\INJECTION\DIPHENHYDRAMINE HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION\DIPHENHYDRAMINE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\DIPHENHYDRAMINE
INTRAMUSCULAR\INJECTION\DIPHENHYDRAMINE
INTRAVENOUS\INJECTION, SOLUTION\DIPHENHYDRAMINE

product(s) by strength(s)

diphenhydramine hydrochloride 50 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006410376ANDAWest-Ward Pharmaceuticals Corp.1972-11-27DIPHENHYDRAMINE HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA080817ec691492-a295-4b48-a1a3-5824931efa97
2633230664ANDAApp Pharmaceuticals, Llc2002-08-01DIPHENHYDRAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA040466921b9f64-1096-46db-866a-67f0f9ff6790, fc574e74-1fdc-4a61-a1ed-492ae43faed2
3674570124ANDAMylan Institutional Llc2013-05-09DIPHENHYDRAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA04049882cd7a3c-acd6-44dc-8c95-f066162a510c

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422540190ANDARebel Distributors Corp1972-11-27DIPHENHYDRAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION006410376ANDA0808178dc7ea67-af85-4187-bf5a-b30878cc3f19
2493490836ANDARemedyrepack Inc.2013-06-13, 2015-07-24DIPHENHYDRAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION006410376ANDA080817154cd985-4f6f-49d1-af49-3a9d54ea1f4b, 2e5c7a03-2925-4bb8-a6d6-81cf0b8a73b4
3521250246ANDARemedyrepack Inc.2013-06-13, 2013-07-10, 2013-11-18DIPHENHYDRAMINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION633230664ANDA040466a70eda52-9332-47c6-b759-f0641dc59813, f69ea3c1-0447-4611-940c-f72ff8cefb69, fb8c5653-2dd5-4c33-a02c-c952e5f31384
4521250636ANDARemedyrepack Inc.2013-06-10, 2013-11-18DIPHENHYDRAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION006410376ANDA0808170b3caf0f-00b6-4b05-9afc-e151e8162e8e, 0d1794ae-8440-4b65-970a-2f1226e3a4aa
5525840376ANDAGeneral Injecatables & Vaccines, Inc2010-07-01DIPHENHYDRAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION006410376ANDA0808174fe466c4-2dd9-42cd-8db8-761f9194d102
6550453683ANDADispensing Solutions, Inc.1972-11-27DIPHENHYDRAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION006410376ANDA0808174c40fb96-819a-4e11-9500-f11cbd51fd6c
7551545102ANDACardinal Health2011-06-28DIPHENHYDRAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION006410376ANDA080817d32d074a-f1b6-4a9a-8e10-e19f0e67c61b
8551549363ANDACardinal Health2002-05-28DIPHENHYDRAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION633230664ANDA04046650df93bf-fe72-48f6-a02e-ea9a313d47c2
9647250376ANDATya Pharmaceuticals1972-11-27DIPHENHYDRAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION006410376ANDA0808172a924d55-3ad6-4efe-88a6-803249bc9900

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040140DIPHENHYDRAMINE HYDROCHLORIDEHOSPIRA INC1998-11-20ANDA040140_001Diphenhydramine Prefilled Syringe
2ANDA040466DIPHENHYDRAMINE HYDROCHLORIDEAPP PHARMACEUTICALS LLC2002-05-28ANDA040466_001Diphenhydramine Prefilled Syringe
3ANDA040498DIPHENHYDRAMINE HYDROCHLORIDEMYLAN INSTITUTIONAL LLC2005-07-12ANDA040498_001Diphenhydramine Prefilled Syringe
4ANDA080577DIPHENHYDRAMINE HYDROCHLORIDETrueWYETH AYERST LABORATORIESANDA080577_001Diphenhydramine Prefilled Syringe
5ANDA080586DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREETrueABRAXIS PHARMACEUTICAL PRODUCTSANDA080586_002Diphenhydramine Prefilled Syringe
6ANDA080817DIPHENHYDRAMINE HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARLANDA080817_002Diphenhydramine Prefilled Syringe
7ANDA080822DIPHENHYDRAMINE HYDROCHLORIDETrueBEL MAR LABORATORIES INCANDA080822_001Diphenhydramine Prefilled Syringe
8ANDA080873DIPHENHYDRAMINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA080873_001, ANDA080873_002, ANDA080873_003Diphenhydramine Prefilled Syringe
9ANDA083183DIPHENHYDRAMINE HYDROCHLORIDETrueHIKMA MAPLE LTDANDA083183_001Diphenhydramine Prefilled Syringe
10ANDA083533DIPHENHYDRAMINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA083533_001Diphenhydramine Prefilled Syringe
11ANDA084094DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREETrueINTERNATIONAL MEDICATION SYSTEMANDA084094_001Diphenhydramine Prefilled Syringe
12ANDA087066DIPHENHYDRAMINE HYDROCHLORIDETrueLYPHOMED DIV FUJISAWA USA INCANDA087066_001Diphenhydramine Prefilled Syringe
13ANDA091526DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREEBD RX INC2013-03-26ANDA091526_001Diphenhydramine Prefilled Syringe
14NDA006146BENADRYLTrueMCNEIL CONSUMER HEALTHCARENDA006146_001, NDA006146_002Diphenhydramine Prefilled Syringe
15NDA009486BENADRYL PRESERVATIVE FREETrueMCNEIL CONSUMER HEALTHCARENDA009486_001Diphenhydramine Prefilled Syringe

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040140_001RXDIPHENHYDRAMINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseAP1998-11-20DIPHENHYDRAMINE HYDROCHLORIDE
2ANDA040466_001RXDIPHENHYDRAMINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseAP2002-05-28DIPHENHYDRAMINE HYDROCHLORIDE
3ANDA040498_001RXDIPHENHYDRAMINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseAP2005-07-12DIPHENHYDRAMINE HYDROCHLORIDE
4ANDA080577_001discontinuedDIPHENHYDRAMINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseDIPHENHYDRAMINE HYDROCHLORIDE
5ANDA080586_002discontinuedDIPHENHYDRAMINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseDIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
6ANDA080817_002RXDIPHENHYDRAMINE HYDROCHLORIDE (50MG/ML)INJECTIONTrueAPDIPHENHYDRAMINE HYDROCHLORIDE
7ANDA080822_001discontinuedDIPHENHYDRAMINE HYDROCHLORIDE (10MG/ML)INJECTIONFalseDIPHENHYDRAMINE HYDROCHLORIDE
8ANDA080873_001discontinuedDIPHENHYDRAMINE HYDROCHLORIDE (10MG/ML)INJECTIONFalseDIPHENHYDRAMINE HYDROCHLORIDE
9ANDA080873_002discontinuedDIPHENHYDRAMINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseDIPHENHYDRAMINE HYDROCHLORIDE
10ANDA080873_003discontinuedDIPHENHYDRAMINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseDIPHENHYDRAMINE HYDROCHLORIDE
11ANDA083183_001discontinuedDIPHENHYDRAMINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseDIPHENHYDRAMINE HYDROCHLORIDE
12ANDA083533_001discontinuedDIPHENHYDRAMINE HYDROCHLORIDE (10MG/ML)INJECTIONFalseDIPHENHYDRAMINE HYDROCHLORIDE
13ANDA084094_001discontinuedDIPHENHYDRAMINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseDIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
14ANDA087066_001discontinuedDIPHENHYDRAMINE HYDROCHLORIDE (10MG/ML)INJECTIONFalseDIPHENHYDRAMINE HYDROCHLORIDE
15ANDA091526_001RXDIPHENHYDRAMINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseAP2013-03-26DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
16NDA006146_001discontinuedDIPHENHYDRAMINE HYDROCHLORIDE (10MG/ML)INJECTIONFalseBENADRYL
17NDA006146_002discontinuedDIPHENHYDRAMINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseBENADRYL
18NDA009486_001discontinuedDIPHENHYDRAMINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseBENADRYL PRESERVATIVE FREE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10b3caf0f-00b6-4b05-9afc-e151e8162e8e (view SPL)Diphenhydramine Hydrochloride Injection, USPRx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-11-181521250636
20d1794ae-8440-4b65-970a-2f1226e3a4aa (view SPL)Diphenhydramine Hydrochloride Injection, USPRx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-101521250636
3154cd985-4f6f-49d1-af49-3a9d54ea1f4b (view SPL)Diphenhydramine Hydrochloride Injection, USPRx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2015-07-241493490836
42a924d55-3ad6-4efe-88a6-803249bc9900 (view SPL)Diphenhydramine Hydrochloride Injection, USP Rx onlyprescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2011-06-132647250376
52e5c7a03-2925-4bb8-a6d6-81cf0b8a73b4 (view SPL)Diphenhydramine Hydrochloride Injection, USPRx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-131493490836
64c40fb96-819a-4e11-9500-f11cbd51fd6c (view SPL)Diphenhydramine Hydrochloride Injection, USPRx onlyprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2011-10-102550453683
74fe466c4-2dd9-42cd-8db8-761f9194d102 (view SPL)Diphenhydramine Hydrochloride Injection, USPRx onlyprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2013-06-064525840376
850df93bf-fe72-48f6-a02e-ea9a313d47c2 (view SPL)Diphenhydramine Hydrochloride Injection, USPRx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2012-04-201551549363
982cd7a3c-acd6-44dc-8c95-f066162a510c (view SPL)prescriptionHuman PrescriptionMylan Institutional Llc2013-01-305674570124
108dc7ea67-af85-4187-bf5a-b30878cc3f19 (view SPL)Diphenhydramine Hydrochloride Injection, USPRx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-03-201422540190
11921b9f64-1096-46db-866a-67f0f9ff6790 (view SPL)DiphenhydrAMINE Hydrochloride Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-09-161633230664
12a70eda52-9332-47c6-b759-f0641dc59813 (view SPL)Diphenhydramine Hydrochloride Injection, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-131521250246
13d32d074a-f1b6-4a9a-8e10-e19f0e67c61b (view SPL)Diphenhydramine Hydrochloride Injection, USPRx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2013-08-134551545102
14ec691492-a295-4b48-a1a3-5824931efa97 (view SPL)Diphenhydramine Hydrochloride Injection, USPRx onlyprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE2011-06-137006410376
15f69ea3c1-0447-4611-940c-f72ff8cefb69 (view SPL)Diphenhydramine Hydrochloride Injection, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-11-181521250246
16fb8c5653-2dd5-4c33-a02c-c952e5f31384 (view SPL)Diphenhydramine Hydrochloride Injection, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-07-101521250246
17fc574e74-1fdc-4a61-a1ed-492ae43faed2 (view SPL)Diphenhydramine Hydrochloride Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-01-241633230664

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