FDA.reportPublic FDA data

NDC 0591-5552 - Metronidazole

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
0591-5552
Package NDCs from labels
0591-5552-50, 0591-5552-01, 0591-5552-25, 0591-5552-05, 0591-5552-10
Manufacturer
Physicians Total Care, Inc.
Effective date
2013-07-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metronidazole - Physicians Total Care, Inc.Physicians Total Care, Inc.2013-07-22HUMAN PRESCRIPTION DRUG LABEL
Metronidazole - Watson LabsWatson Labs2006-11-27HUMAN PRESCRIPTION DRUG LABELING
Metronidazole - Watson LabsWatson Labs2006-02-06HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-5552-01Metronidazole100 in 1 BOTTLETABLET1003
0591-5552-05Metronidazole500 in 1 BOTTLETABLET5003
0591-5552-10Metronidazole1000 in 1 BOTTLETABLET10003
0591-5552-25Metronidazole250 in 1 BOTTLETABLET2503
0591-5552-50Metronidazole50 in 1 BOTTLETABLET503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5552METRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]35 package rows20061208_A66ABF44-9AE9-4342-B69A-EBAA1F9B7D78.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MetronidazoleACTIVE INGREDIENT140QMO216EMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]3
metronidazoleACTIVE MOIETY140QMO216EMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]3
Colloidial silicon dioxideINACTIVE INGREDIENTMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]3
CrospovidoneINACTIVE INGREDIENTMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]3
Hydrogenated vegtable oilINACTIVE INGREDIENTMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]3
Microcrystalline celluloseINACTIVE INGREDIENTMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]3
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]2
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETRONIDAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]2
MetronidazoleACTIVE INGREDIENT140QMO216EMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]1
MetronidazoleACTIVE MOIETY140QMO216EMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]1
Colloidial silicon dioxideINACTIVE INGREDIENTMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]1
CrospovidoneINACTIVE INGREDIENTMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]1
Hydrogenated vegtable oilINACTIVE INGREDIENTMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]1
Microcrystalline celluloseINACTIVE INGREDIENTMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]1

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 3 of 38 · 758 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack5cf3cc1f-601e-4997-bfb2-a573c31c81892026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314106
unii: 140QMO216E
MetronidazoleMETRONIDAZOLESun Pharmaceutical Industries, Inc.4a233572-2471-4e99-a45e-2de978abcf162026-07-15Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLESun Pharmaceutical Industries, Inc.5a504f74-bccd-433a-bd5b-6822f98c34df2026-07-15Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLESun Pharmaceutical Industries, Inc.5842a554-58d1-4ee4-99aa-1e6029a69be22026-07-15Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack4748ba37-9d66-497d-aa9f-ca2d541c5f412026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311681
unii: 140QMO216E
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
MetronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.59e53582-244a-4e9d-b18e-75dddc6a50522026-07-08Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.cfeab9e3-58b9-4890-9185-11b62904e2af2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314106
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.cbee69e8-029c-49d2-89cd-f504b8e0ac282026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311681
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.3e0a14f1-961b-4722-bfea-aafcc5d7706c2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314106
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.53918705-d2fe-4c6b-9501-a619a8ad39912026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311681
unii: 140QMO216E
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
MetronidazoleMETRONIDAZOLEKanchan Healthcare Inc8836334e-6db4-44be-bc9e-099b26322cf42026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314106
rxcui: 311681
unii: 140QMO216E
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
metronidazoleMETRONIDAZOLEBryant Ranch Prepack99886f54-4ebe-4a2d-b779-bcfbb0634db12026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
PYLERABISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDEH2-Pharma, LLC5cdacbf5-67be-42eb-bd54-8acc32ea1abc2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.49bed450-7fa8-401c-8c8c-afc1c61d473a2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311681
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.3c0ebb00-a0ae-4f64-9bfc-de01193191e82026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311681
unii: 140QMO216E
MetronidazoleMETRONIDAZOLECoupler LLC545f2900-745c-c33c-e063-6294a90a5e4f2026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311681
unii: 140QMO216E

Reported adverse events (FAERS/openFDA)#

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