FDA.reportPublic FDA data

NDC 54868-2007-1 - Chlorthalidone

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
54868-2007
Requested NDC
54868-2007-1
Package NDCs from labels
54868-2007-0, 54868-2007-2, 54868-2007-1
Manufacturer
Physicians Total Care, Inc.
Effective date
2015-05-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Chlorthalidone - Physicians Total Care, Inc.Physicians Total Care, Inc.2015-05-07HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54868-2007-02019-09-24C16284748780-19350213a-40b5-c013-e053-90daa90a1393950bb805-3ca7-4f54-b4fb-c9e23cb33ae2
54868-2007-22019-09-24C16284748780-19350213a-40b5-c013-e053-90daa90a1393950bb805-3ca7-4f54-b4fb-c9e23cb33ae2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-2007-0Chlorthalidone30 in 1 BOTTLE, PLASTICTABLET304
54868-2007-2Chlorthalidone90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-2007CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]42 package rows20150507_950bb805-3ca7-4f54-b4fb-c9e23cb33ae2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-2007-0EA - Each54868-200754b3c9bb-c7bc-466c-8b04-f9698c4022d812012-07-24
54868-2007-1EA - Each54868-2007952f9962-8144-4489-b29c-e79dbe91591a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORTHALIDONEACTIVE INGREDIENTQ0MQD1073QCHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]4
CHLORTHALIDONEACTIVE MOIETYQ0MQD1073QCHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]4

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 31 of 35 · 692 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic CombinationCALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEAOHM PHARMA INC.044a7174-f7a3-490f-9cad-01f2665d75752022-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
ChlorthalidoneCHLORTHALIDONENorthstar Rx LLC.56635d7a-1fff-4d1f-bf2c-def4b1ad82082022-11-24Warnings, Adverse reactionsExact identifier
rxcui: 197500
rxcui: 197499
unii: Q0MQD1073Q
ChlorthalidoneCHLORTHALIDONEUnichem Pharmaceuticals (USA), Inc.01065eda-7515-46bc-b858-a062c3aa35bd2022-11-24Warnings, Adverse reactionsExact identifier
rxcui: 197500
rxcui: 197499
unii: Q0MQD1073Q
4 Kids Cold and Mucus NighttimeEUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFURHyland's Inc.6f7b2585-2f0e-5938-e053-2a91aa0aa9d12022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
4 Kids Complete Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.ef39fe3d-a42d-4baa-9199-91f664feb4322022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
ChlorthalidoneCHLORTHALIDONESun Pharmaceutical Industries, Inc.a304de67-cd2b-4933-937e-4eeecf6cda402022-11-04Warnings, Adverse reactionsExact identifier
rxcui: 197500
rxcui: 197499
unii: Q0MQD1073Q
CHLORTHALIDONECHLORTHALIDONEJUBILANT CADISTA PHARMACEUTICALS,INC.ca0df4ae-c424-44d2-8611-1637f1a101a82022-11-03Warnings, Adverse reactionsExact identifier
rxcui: 197500
rxcui: 197499
unii: Q0MQD1073Q
ChlorthalidoneCHLORTHALIDONEZydus Pharmaceuticals USA Inc.ef8023a3-b2be-436e-9085-5767819506652022-10-05Warnings, Adverse reactionsExact identifier
rxcui: 197500
rxcui: 197499
unii: Q0MQD1073Q
CHLORTHALIDONE CHLORTHALIDONECHLORTHALIDONEAlembic Pharmaceuticals Limited1b98d1a1-9d3d-41d2-a5e9-744b851d30d42022-09-06Warnings, Adverse reactionsExact identifier
rxcui: 197500
rxcui: 197499
unii: Q0MQD1073Q
CHLORTHALIDONE CHLORTHALIDONECHLORTHALIDONEAlembic Pharmaceuticals Inc.a1043a72-8e64-49da-a7e4-eadee083022e2022-08-29Warnings, Adverse reactionsExact identifier
rxcui: 197500
rxcui: 197499
unii: Q0MQD1073Q
Hendel Periodontal and Tooth Pain ReliefSODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDEMediNatura Incf34e9f77-69fd-4c7f-9eea-2d721a4d27fb2022-08-22WarningsExact identifier
unii: ETJ7Z6XBU4
EdarbyclorAZILSARTAN KAMEDOXOMIL AND CHLORTHALIDONEAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)e60f795b-fce3-4361-aa03-f143451689d12022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q0MQD1073Q
ChlorthalidoneCHLORTHALIDONETAGI Pharma, Inc.bd92c59b-3a65-47c3-b3c8-37090b4ae4642022-06-22Warnings, Adverse reactionsExact identifier
rxcui: 197500
rxcui: 197499
unii: Q0MQD1073Q
ChlorthalidoneCHLORTHALIDONEProficient Rx LP01337f79-4b3d-4749-a82b-8d56c1aec1792022-05-01Warnings, Adverse reactionsExact identifier
rxcui: 197499
unii: Q0MQD1073Q
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe Mexico, S.A. de C.V.3e2e5f52-db54-4635-83a8-a67a683c093c2022-03-22WarningsExact identifier
unii: ETJ7Z6XBU4
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe North America, Inc.94de9ce3-6ee9-4322-bda2-0b4391f09d872022-03-22WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUMNewton Laboratories, Inc.da807eb3-34a3-61b9-e053-2995a90a0e212022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da80a5ea-f603-719e-e053-2995a90a97102022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da81b21a-090a-dabf-e053-2995a90aa05e2022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da821d05-b2f0-3582-e053-2a95a90afe592022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.