FDA.reportPublic FDA data

Metronidazole

Product NDC
50111-333
11-digit product format
501110333
Labeler code
50111
Product ID
50111-333_c6f82723-a668-4dc1-96ea-816620a5b964
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA070027
Marketing category
ANDA
Marketing start
1990-09-30
Substance
METRONIDAZOLE
Active strength
250 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metronidazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRONIDAZOLE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii140QMO216E
Rxcui311681, 314106

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55Product name520251024
7f6d14e0-4366-41bc-a4a9-b74c79a20e17Product name120250623
e6d321b0-0e5e-7da6-f043-92b6a91f00a1Product name520250515
e1aac33b-94ae-4ee9-905b-299f7263853bProduct name320250124
16642716-d28a-4f90-8dcb-3921cd8c8109Product name420240516
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
a5070875-62bb-61e1-fd46-8f7054197a40Product name820180215
0add4de9-d152-3375-3390-1123dddc5e3dProduct name120140508
33ca0fcc-1011-92dc-50a9-a383683eed1eProduct name120140508
53f39d9f-cd3f-04e1-c668-d4580719d57dProduct name120140508
a804000f-b74f-0b5d-d17b-aa767c286ddbProduct name120140508
a91ea265-6e02-c08f-93c8-686d54180529Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50111-333-01Metronidazole100 in 1 BOTTLETABLET10018
50111-333-02Metronidazole500 in 1 BOTTLETABLET50018
50111-333-06Metronidazole250 in 1 BOTTLETABLET25018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50111-333-01EA - Each50111-3332cd6c74a-f102-4e47-acec-526dda67f0ac12012-07-24
50111-333-02EA - Each50111-3336e376328-fcdd-499f-9fa1-68787cf94e7d12012-07-24
50111-333-06EA - Each50111-333dce9a85d-bc92-4ca6-847c-62f06cf6ea5912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [READYMEDS]5
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [PLIVA INC.]5
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [READYMEDS]5
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [PLIVA INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [READYMEDS]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [PLIVA INC.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETRONIDAZOLE TABLET [READYMEDS]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETRONIDAZOLE TABLET [PLIVA INC.]5
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAMETRONIDAZOLE TABLET [PLIVA INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [PLIVA INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [READYMEDS]5
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]4
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]4
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAMETRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]4
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE (METRONIDAZOLE) TABLET [STAT RX USA LLC]2
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [CARILION MATERIALS MANAGEMENT]2
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [CARILION MATERIALS MANAGEMENT]2
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE (METRONIDAZOLE) TABLET [STAT RX USA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE (METRONIDAZOLE) TABLET [STAT RX USA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [CARILION MATERIALS MANAGEMENT]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETRONIDAZOLE TABLET [CARILION MATERIALS MANAGEMENT]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETRONIDAZOLE (METRONIDAZOLE) TABLET [STAT RX USA LLC]2
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAMETRONIDAZOLE (METRONIDAZOLE) TABLET [STAT RX USA LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE (METRONIDAZOLE) TABLET [STAT RX USA LLC]2
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [PROFICIENT RX LP]1
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]1
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]1
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETRONIDAZOLE TABLET [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]1
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAMETRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAMETRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]1
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAMETRONIDAZOLE TABLET [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50111-333METRONIDAZOLE TABLET [TEVA PHARMACEUTICALS USA, INC.]18Current NDC, Legacy NDC, 3 package rows20240724_291a45f6-ed27-4dcc-8364-358d08623797.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSNabc82bde-a38a-4fa2-a7be-89bb03ede06626
314106metronidazole 250 MG Oral TabletSCDabc82bde-a38a-4fa2-a7be-89bb03ede06626
314106metroNIDAZOLE 250 MG Oral TabletPSNca450fad-0513-4c45-8ea0-1f46bcbf6a3621
314106metronidazole 250 MG Oral TabletSCDca450fad-0513-4c45-8ea0-1f46bcbf6a3621
314106metroNIDAZOLE 250 MG Oral TabletPSN291a45f6-ed27-4dcc-8364-358d0862379718
311681metroNIDAZOLE 500 MG Oral TabletPSN291a45f6-ed27-4dcc-8364-358d0862379718
314106metronidazole 250 MG Oral TabletSCD291a45f6-ed27-4dcc-8364-358d0862379718
311681metronidazole 500 MG Oral TabletSCD291a45f6-ed27-4dcc-8364-358d0862379718
314106metroNIDAZOLE 250 MG Oral TabletPSNea635d05-b3c1-4f49-ace2-d091c20920da6
314106metronidazole 250 MG Oral TabletSCDea635d05-b3c1-4f49-ace2-d091c20920da6
314106metroNIDAZOLE 250 MG Oral TabletPSN205054e1-8172-47dc-931c-a18a60e7e9f05
314106metroNIDAZOLE 250 MG Oral TabletPSN73485c4f-acc0-46a3-8226-8d5d7bd6e1095
314106metronidazole 250 MG Oral TabletSCD205054e1-8172-47dc-931c-a18a60e7e9f05
314106metronidazole 250 MG Oral TabletSCD73485c4f-acc0-46a3-8226-8d5d7bd6e1095
314106metroNIDAZOLE 250 MG Oral TabletPSNa775da83-6554-4229-afb8-92cdcfb4503e4
311681metroNIDAZOLE 500 MG Oral TabletPSNa775da83-6554-4229-afb8-92cdcfb4503e4
314106metronidazole 250 MG Oral TabletSCDa775da83-6554-4229-afb8-92cdcfb4503e4
311681metronidazole 500 MG Oral TabletSCDa775da83-6554-4229-afb8-92cdcfb4503e4
314106metroNIDAZOLE 250 MG Oral TabletPSN474085d2-383e-40c1-ab9d-57c7669b4ad53
314106metronidazole 250 MG Oral TabletSCD474085d2-383e-40c1-ab9d-57c7669b4ad53
314106metroNIDAZOLE 250 MG Oral TabletPSN3193a61d-acc4-445a-8bb9-328568d439372
314106metroNIDAZOLE 250 MG Oral TabletPSN65e8c166-82fb-4363-8633-c9e4ad6de4fd2
311681metroNIDAZOLE 500 MG Oral TabletPSN3193a61d-acc4-445a-8bb9-328568d439372
314106metronidazole 250 MG Oral TabletSCD65e8c166-82fb-4363-8633-c9e4ad6de4fd2
314106metronidazole 250 MG Oral TabletSCD3193a61d-acc4-445a-8bb9-328568d439372
311681metronidazole 500 MG Oral TabletSCD3193a61d-acc4-445a-8bb9-328568d439372
314106metroNIDAZOLE 250 MG Oral TabletPSN5911e8f2-1b3a-4222-b997-d2a1c9a9f5351
314106metroNIDAZOLE 250 MG Oral TabletPSNd552db0a-959c-4ad9-ab65-d7cc541baf7e1
314106metroNIDAZOLE 250 MG Oral TabletPSN2b5f951e-4b6a-2c1f-e054-00144ff8d46c1
311681metroNIDAZOLE 500 MG Oral TabletPSN5911e8f2-1b3a-4222-b997-d2a1c9a9f5351
311681metroNIDAZOLE 500 MG Oral TabletPSNd552db0a-959c-4ad9-ab65-d7cc541baf7e1
314106metronidazole 250 MG Oral TabletSCD5911e8f2-1b3a-4222-b997-d2a1c9a9f5351
314106metronidazole 250 MG Oral TabletSCD2b5f951e-4b6a-2c1f-e054-00144ff8d46c1
314106metronidazole 250 MG Oral TabletSCDd552db0a-959c-4ad9-ab65-d7cc541baf7e1
311681metronidazole 500 MG Oral TabletSCD5911e8f2-1b3a-4222-b997-d2a1c9a9f5351
311681metronidazole 500 MG Oral TabletSCDd552db0a-959c-4ad9-ab65-d7cc541baf7e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50111-333-0150111033301100 TABLET in 1 BOTTLE (50111-333-01) 100 tablet1990-09-300000-00-00NoNoCurrent
50111-333-0250111033302500 TABLET in 1 BOTTLE (50111-333-02) 500 tablet1990-09-300000-00-00NoNoCurrent
50111-333-0650111033306250 TABLET in 1 BOTTLE (50111-333-06) 250 tablet1990-09-300000-00-00NoNoCurrent