FDA.reportPublic FDA data

Metronidazole

Product NDC
71335-0358
11-digit product format
713350358
Labeler code
71335
Product ID
71335-0358_8bc02400-bfe9-4bf1-93b4-f5d287812a8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203458
Marketing category
ANDA
Marketing start
2014-06-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0358-0Metronidazole40 in 1 BOTTLETABLET, FILM COATED4010
71335-0358-1Metronidazole20 in 1 BOTTLETABLET, FILM COATED2010
71335-0358-2Metronidazole30 in 1 BOTTLETABLET, FILM COATED3010
71335-0358-3Metronidazole14 in 1 BOTTLETABLET, FILM COATED1410
71335-0358-4Metronidazole56 in 1 BOTTLETABLET, FILM COATED5610
71335-0358-5Metronidazole21 in 1 BOTTLETABLET, FILM COATED2110
71335-0358-6Metronidazole4 in 1 BOTTLETABLET, FILM COATED410
71335-0358-7Metronidazole28 in 1 BOTTLETABLET, FILM COATED2810
71335-0358-8Metronidazole100 in 1 BOTTLETABLET, FILM COATED10010
71335-0358-9Metronidazole42 in 1 BOTTLETABLET, FILM COATED4210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0358-0EA - Each71335-035887617595-475f-446f-9706-fa87a107938212018-01-12
71335-0358-1EA - Each71335-0358969322eb-f3be-4d52-83cd-d6af32148fc412018-01-12
71335-0358-2EA - Each71335-0358edd0b825-c20e-4ce0-b5c5-b17ff806881512018-01-12
71335-0358-3EA - Each71335-035881626941-79bc-423c-80f6-6e1282a5a56512018-01-12
71335-0358-4EA - Each71335-035860991bed-53d0-42ec-a967-24de2787f81d12018-01-12
71335-0358-5EA - Each71335-0358689f1915-b26f-439c-823f-8c890e567f1a12018-01-12
71335-0358-6EA - Each71335-0358b26c3238-be55-43da-8dd3-801c04591fc712018-01-12
71335-0358-7EA - Each71335-035880c8b6b1-d6f1-4766-b09e-deb89991bfc512018-01-12
71335-0358-8EA - Each71335-0358265ec76b-72e1-4e19-9884-25840ad441b312018-01-12
71335-0358-9EA - Each71335-0358741cbcb7-7732-4362-947a-37783f53186c12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0358METRONIDAZOLE TABLET, FILM COATED [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 10 package rows20240809_cdd942a1-fb3b-4912-bd3f-8aef451e6a3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSNcdd942a1-fb3b-4912-bd3f-8aef451e6a3c10
311681metronidazole 500 MG Oral TabletSCDcdd942a1-fb3b-4912-bd3f-8aef451e6a3c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0358-07133503580040 TABLET, FILM COATED in 1 BOTTLE (71335-0358-0) 2018-11-070000-00-00NoNoCurrent
71335-0358-17133503580120 TABLET, FILM COATED in 1 BOTTLE (71335-0358-1) 2018-02-270000-00-00NoNoCurrent
71335-0358-27133503580230 TABLET, FILM COATED in 1 BOTTLE (71335-0358-2) 2018-02-200000-00-00NoNoCurrent
71335-0358-37133503580314 TABLET, FILM COATED in 1 BOTTLE (71335-0358-3) 2018-03-280000-00-00NoNoCurrent
71335-0358-47133503580456 TABLET, FILM COATED in 1 BOTTLE (71335-0358-4) 2024-04-050000-00-00NoNoCurrent
71335-0358-57133503580521 TABLET, FILM COATED in 1 BOTTLE (71335-0358-5) 2018-08-030000-00-00NoNoCurrent
71335-0358-6713350358064 TABLET, FILM COATED in 1 BOTTLE (71335-0358-6) 2018-10-260000-00-00NoNoCurrent
71335-0358-77133503580728 TABLET, FILM COATED in 1 BOTTLE (71335-0358-7) 2018-05-290000-00-00NoNoCurrent
71335-0358-871335035808100 TABLET, FILM COATED in 1 BOTTLE (71335-0358-8) 2018-06-120000-00-00NoNoCurrent
71335-0358-97133503580942 TABLET, FILM COATED in 1 BOTTLE (71335-0358-9) 2019-07-290000-00-00NoNoCurrent