FDA.reportPublic FDA data

Metronidazole

Product NDC
63629-1386
11-digit product format
636291386
Labeler code
63629
Product ID
63629-1386_7a0f2236-cf51-409f-94f9-ce62135b27ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA070033
Marketing category
ANDA
Marketing start
1990-09-30
Substance
METRONIDAZOLE
Active strength
500 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
METRONIDAZOLE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii140QMO216E
Rxcui311681

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-1386-02020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-12020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-22020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-32020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-42020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-52020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-62020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-72020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-82020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-92020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-02020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-12020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-22020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-32020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-42020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-52020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-62020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-72020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-82020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1386-92020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1386-0Metronidazole40 in 1 BOTTLETABLET4029
63629-1386-1Metronidazole20 in 1 BOTTLETABLET2029
63629-1386-2Metronidazole30 in 1 BOTTLETABLET3029
63629-1386-3Metronidazole14 in 1 BOTTLETABLET1429
63629-1386-4Metronidazole56 in 1 BOTTLETABLET5629
63629-1386-5Metronidazole21 in 1 BOTTLETABLET2129
63629-1386-6Metronidazole4 in 1 BOTTLETABLET429
63629-1386-7Metronidazole28 in 1 BOTTLETABLET2829
63629-1386-8Metronidazole100 in 1 BOTTLETABLET10029
63629-1386-9Metronidazole60 in 1 BOTTLETABLET6029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1386-1EA - Each63629-13868f450d6b-8d77-405f-a61a-1823e4e970e012012-07-24
63629-1386-2EA - Each63629-1386eab303ef-b6a7-4fc6-8406-b7847498c1f612012-07-24
63629-1386-3EA - Each63629-13868586131f-b4d9-493a-aa26-82e0ae1d0ef212012-07-24
63629-1386-4EA - Each63629-1386a387956a-afdc-46d3-bd61-5157f69151d812012-07-24
63629-1386-5EA - Each63629-1386614ae12b-85d2-4bed-a2ac-edf676b5b3e912012-07-24
63629-1386-6EA - Each63629-1386b1237d1f-3020-4121-8d87-fb3b83de7fc812012-07-24
63629-1386-7EA - Each63629-1386b1350ff4-6647-4f85-8783-2e1cbb0b52fc12012-07-24
63629-1386-8EA - Each63629-1386ff531004-8cb1-4ecf-997e-ac3c32fed7e112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [BRYANT RANCH PREPACK]3
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [BRYANT RANCH PREPACK]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [BRYANT RANCH PREPACK]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETRONIDAZOLE TABLET [BRYANT RANCH PREPACK]3
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAMETRONIDAZOLE TABLET [BRYANT RANCH PREPACK]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [BRYANT RANCH PREPACK]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1386METRONIDAZOLE TABLET [BRYANT RANCH PREPACK]29Current NDC, Legacy NDC, 10 package rows20241105_e1e7e127-e99e-80e9-1606-71261658b0c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSNe1e7e127-e99e-80e9-1606-71261658b0c129
311681metronidazole 500 MG Oral TabletSCDe1e7e127-e99e-80e9-1606-71261658b0c129

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1386-06362913860040 TABLET in 1 BOTTLE (63629-1386-0) 40 tablet2010-08-030000-00-00NoNoCurrent
63629-1386-16362913860120 TABLET in 1 BOTTLE (63629-1386-1) 20 tablet2004-12-160000-00-00NoNoCurrent
63629-1386-26362913860230 TABLET in 1 BOTTLE (63629-1386-2) 30 tablet2004-12-200000-00-00NoNoCurrent
63629-1386-36362913860314 TABLET in 1 BOTTLE (63629-1386-3) 14 tablet2007-03-260000-00-00NoNoCurrent
63629-1386-46362913860456 TABLET in 1 BOTTLE (63629-1386-4) 56 tablet2006-08-100000-00-00NoNoCurrent
63629-1386-56362913860521 TABLET in 1 BOTTLE (63629-1386-5) 21 tablet2009-02-120000-00-00NoNoCurrent
63629-1386-6636291386064 TABLET in 1 BOTTLE (63629-1386-6) 4 tablet2008-06-120000-00-00NoNoCurrent
63629-1386-76362913860728 TABLET in 1 BOTTLE (63629-1386-7) 28 tablet2008-07-070000-00-00NoNoCurrent
63629-1386-863629138608100 TABLET in 1 BOTTLE (63629-1386-8) 100 tablet2010-08-260000-00-00NoNoCurrent
63629-1386-96362913860960 TABLET in 1 BOTTLE (63629-1386-9) 60 tablet2022-03-080000-00-00NoNoCurrent