Sodium Bicarbonate Injectable Solution

Brand(s)
Neut brand of sodium bicarbonate
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2014-08-21)
Oldest Current Product
1984-01-27
License(s)
ANDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTABLE SOLUTION\SODIUM BICARBONATE
FDAOB
INJECTION\INJECTION\SODIUM BICARBONATE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\SODIUM BICARBONATE
INTRAVENOUS\INJECTION\SODIUM BICARBONATE
INTRAVENOUS\SOLUTION\SODIUM BICARBONATE
PARENTERAL\INJECTION\SODIUM BICARBONATE
PARENTERAL\SOLUTION\SODIUM BICARBONATE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\BICARBONATE ION
INTRAVENOUS\INJECTION, SOLUTION\SODIUM CATION
INTRAVENOUS\INJECTION\BICARBONATE ION
INTRAVENOUS\INJECTION\SODIUM CATION
INTRAVENOUS\SOLUTION\BICARBONATE ION
PARENTERAL\INJECTION\SODIUM CATION
PARENTERAL\SOLUTION\BICARBONATE ION

product(s) by strength(s)

sodium bicarbonate 0.5 meq/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productspl
1004095534UNAPPROVED DRUG OTHER MARKETING CATEGORYHospira, Inc.1984-01-27SODIUM BICARBONATEINTRAVENOUSINJECTION, SOLUTIONc814823a-c58b-4697-877c-47af6246f1cd
2005483331UNAPPROVED DRUG OTHER MARKETING CATEGORYAmphastar Pharmaceuticals, Inc.2000-06-012009-12-31SODIUM BICARBONATEPARENTERALINJECTIONc1ab9fff-c97b-4fca-b7a2-2378045bc799
3525840534UNAPPROVED DRUG OTHER MARKETING CATEGORYGeneral Injecatables & Vaccines, Inc2010-03-01SODIUM BICARBONATEINTRAVENOUSINJECTION, SOLUTION00409553448d7556f-5b44-4d32-ac74-a9c1a306647f
4551544737UNAPPROVED DRUG OTHER MARKETING CATEGORYCardinal Health1984-01-27SODIUM BICARBONATEINTRAVENOUSINJECTION, SOLUTION004095534d37d6c0a-f46a-49f3-b4eb-88df55ac22dc
5633230026UNAPPROVED DRUG OTHER MARKETING CATEGORYApp Pharmaceuticals, Llc2000-08-10SODIUM BICARBONATEINTRAVENOUSSOLUTIONbcc61f10-83df-4b08-8e22-801c4826063e

sodium bicarbonate 0.893 meq/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productspl
1525840639UNAPPROVED DRUG OTHER MARKETING CATEGORYGeneral Injecatables & Vaccines, Inc2010-08-01SODIUM BICARBONATEINTRAVENOUSINJECTION, SOLUTION005170639fb86592a-fdfa-453b-b5c9-bf93b9ea35f8

sodium bicarbonate 0.9 meq/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productspl
1525840916UNAPPROVED DRUG OTHER MARKETING CATEGORYGeneral Injecatables & Vaccines, Inc2011-03-10SODIUM BICARBONATEINTRAVENOUSINJECTION004094916f42c680d-1d80-4091-b794-17e07af10b2e

sodium bicarbonate 1 meq/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1004096625UNAPPROVED DRUG OTHER MARKETING CATEGORYHospira, Inc.1985-04-18, 2014-03-13SODIUM BICARBONATEINTRAVENOUSINJECTION, SOLUTIONc814823a-c58b-4697-877c-47af6246f1cd, fe82c0e8-90e2-49e5-8a82-597d3484d84f
2505090100UNAPPROVED DRUG OTHER MARKETING CATEGORYOnpharma, Inc.2010-07-22SODIUM BICARBONATEPARENTERALSOLUTIONf9c826a7-8f19-4857-b5be-11dcafcfc7a9

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840625UNAPPROVED DRUG OTHER MARKETING CATEGORYGeneral Injecatables & Vaccines, Inc2010-08-01SODIUM BICARBONATEINTRAVENOUSINJECTION, SOLUTION0040966252d05e1e4-0891-411d-a435-1280991fa79f
2525840637ANDAGeneral Injecatables & Vaccines, Inc2010-08-01SODIUM BICARBONATEINTRAVENOUSINJECTION, SOLUTION004096637ANDA0773943baaf6d5-6dd4-4b9e-aa04-c5929bd43967
3525840900UNAPPROVED DRUG OTHER MARKETING CATEGORYGeneral Injecatables & Vaccines, Inc2010-08-01SODIUM BICARBONATEINTRAVENOUSINJECTION, SOLUTION004094900cde42e87-0055-459f-934e-bab97d1f6a7b
4551540119UNAPPROVED DRUG OTHER MARKETING CATEGORYCardinal Health1985-04-18SODIUM BICARBONATEINTRAVENOUSINJECTION, SOLUTION004096625824b02bc-2b5e-4ee5-9d96-d4c1148ed568
5551543197UNAPPROVED DRUG OTHER MARKETING CATEGORYCardinal Health1985-04-18SODIUM BICARBONATEINTRAVENOUSINJECTION, SOLUTION004096637824b02bc-2b5e-4ee5-9d96-d4c1148ed568
6551544738UNAPPROVED DRUG OTHER MARKETING CATEGORYCardinal Health1985-05-01SODIUM BICARBONATEINTRAVENOUSINJECTION, SOLUTION004094900b61ee9b5-da0d-4b12-95ad-a7202ae088be
7551546995UNAPPROVED DRUG OTHER MARKETING CATEGORYCardinal Health1985-04-18SODIUM BICARBONATEINTRAVENOUSINJECTION, SOLUTION0040966254656a98c-f339-4144-b30a-3bb2168eb342
8616996625UNAPPROVED DRUG OTHER MARKETING CATEGORYUs Medsource, Llc2014-07-03SODIUM BICARBONATEINTRAVENOUSINJECTION, SOLUTION0040966252a262fe3-8a64-4dc5-954a-1d51fb72747b
9617860216UNAPPROVED DRUG OTHER MARKETING CATEGORYRemedyrepack Inc.2015-03-07SODIUM BICARBONATEINTRAVENOUSINJECTION, SOLUTION004096625a8470581-bacf-4f7a-a3b2-79d728ba3fe8

sodium bicarbonate 40 mg/ml injectable solution

product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productspl
1004096609Neut brand of sodium bicarbonateUNAPPROVED DRUG OTHER MARKETING CATEGORYHospira, Inc.2005-08-22, 2014-05-03SODIUM BICARBONATEINTRAVENOUSINJECTION, SOLUTIONca2906bc-7d85-449b-bc86-ed627bf69a9f, ea98e19f-0b58-4305-8984-7f871062d309
2525840609Neut brand of sodium bicarbonateUNAPPROVED DRUG OTHER MARKETING CATEGORYGeneral Injecatables & Vaccines, Inc2014-07-31SODIUM BICARBONATEINTRAVENOUSINJECTION004096609f45ef7b7-1ea3-4c99-a850-31305aabb55d

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA077394SODIUM BICARBONATEHOSPIRA INC2005-11-09ANDA077394_001, ANDA077394_002Sodium Bicarbonate Prefilled Syringe
2NDA019443SODIUM BICARBONATE IN PLASTIC CONTAINERTrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV1986-06-03NDA019443_001, NDA019443_002Sodium Bicarbonate Prefilled Syringe

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1ANDA077394_001RXSODIUM BICARBONATE (0.9MEQ/ML)INJECTIONTrue2005-11-09SODIUM BICARBONATE
2ANDA077394_002RXSODIUM BICARBONATE (1MEQ/ML)INJECTIONTrue2005-11-09SODIUM BICARBONATE
3NDA019443_001discontinuedSODIUM BICARBONATE (0.9MEQ/ML)INJECTIONFalse1986-06-03SODIUM BICARBONATE IN PLASTIC CONTAINER
4NDA019443_002discontinuedSODIUM BICARBONATE (1MEQ/ML)INJECTIONFalse1986-06-03SODIUM BICARBONATE IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
12a262fe3-8a64-4dc5-954a-1d51fb72747b (view SPL)SODIUM BICARBONATE Injection, USPprescriptionHuman PrescriptionUs Medsource, Llcrepack2014-07-031616996625
22d05e1e4-0891-411d-a435-1280991fa79f (view SPL)8.4% Sodium Bicarbonate 1 mEq/mL Injection, USP 50 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-04-232525840625
33baaf6d5-6dd4-4b9e-aa04-c5929bd43967 (view SPL)8.4% Sodium Bicarbonate 1 mEq/mL Injection, USP 50 mL Abboject SyringeprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-08-271525840637
44656a98c-f339-4144-b30a-3bb2168eb342 (view SPL)SODIUM BICARBONATE Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-05-131551546995
548d7556f-5b44-4d32-ac74-a9c1a306647f (view SPL)Infant Sodium Bicarbonate 4.2% Injection, USP 10 mL Abboject SyringeprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-04-202525840534
6824b02bc-2b5e-4ee5-9d96-d4c1148ed568 (view SPL)SODIUM BICARBONATE Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-09-163551540119, 551543197
7a8470581-bacf-4f7a-a3b2-79d728ba3fe8 (view SPL)SODIUM BICARBONATE Injection, USPprescriptionHuman PrescriptionRemedyrepack Inc.2015-03-071617860216
8b61ee9b5-da0d-4b12-95ad-a7202ae088be (view SPL)SODIUM BICARBONATE Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-05-271551544738
9bcc61f10-83df-4b08-8e22-801c4826063e (view SPL)Sodium BicarbonateprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-08-311633230026
10c1ab9fff-c97b-4fca-b7a2-2378045bc799 (view SPL)Sodium Bicarbonate Injection, USPprescriptionHuman PrescriptionAmphastar Pharmaceuticals, Inc.2010-09-203005483331, 005481052, 005482052, 005483352Sodium Bicarbonate Prefilled Syringe
11c814823a-c58b-4697-877c-47af6246f1cd (view SPL)SODIUM BICARBONATE Injection, USPprescriptionHuman PrescriptionHospira, Inc.2012-08-131004095534, 004096625, 004094900, 004094916, 004096637Sodium Bicarbonate Prefilled Syringe
12ca2906bc-7d85-449b-bc86-ed627bf69a9f (view SPL)Neut 4% SODIUM BICARBONATE ADDITIVE SOLUTIONprescriptionHuman PrescriptionHospira, Inc.2012-10-241004096609
13cde42e87-0055-459f-934e-bab97d1f6a7b (view SPL)8.4% Sodium Bicarbonate 1 mEq/mL Injection, USP 10 mL Abboject SyringeprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-04-233525840900
14d37d6c0a-f46a-49f3-b4eb-88df55ac22dc (view SPL)SODIUM BICARBONATE Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-05-271551544737
15ea98e19f-0b58-4305-8984-7f871062d309 (view SPL)NeutTM SODIUM BICARBONATE 4% 2.4 mEq/5 mL (0.48 mEq/mL)prescriptionHuman PrescriptionHospira, Inc.2014-08-211004096609
16f42c680d-1d80-4091-b794-17e07af10b2e (view SPL)7.5% Sodium Bicarbonate Inj. USP 50 mLprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-03-101525840916
17f45ef7b7-1ea3-4c99-a850-31305aabb55d (view SPL)NeutprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2014-07-311525840609
18f6043edd-d19b-43fb-a442-05f3503226fd (view SPL)Sodium Bicarbonate Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-08-042633230006
19f9c826a7-8f19-4857-b5be-11dcafcfc7a9 (view SPL)SODIUM BICARBONATE INJ., 8.4% USP NEUTRALIZING ADDITIVE SOLUTION Rx only Volume 2.7 mL per cartridge 2.7 mEq (1mEq/mL) Volume 1.7 mL per cartridge 1.7 mEq (1mEq/mL)prescriptionHuman PrescriptionOnpharma, Inc.manufacture2014-01-3119505090100
20fb86592a-fdfa-453b-b5c9-bf93b9ea35f8 (view SPL)Sodium Bicarbonate 7.5% 3.75 gm Injection, USP 50 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-08-271525840639
21fe82c0e8-90e2-49e5-8a82-597d3484d84f (view SPL)SODIUM BICARBONATEInjection, USPprescriptionHuman PrescriptionHospira, Inc.2014-07-071004096625

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