FDA.reportPublic FDA data

Metronidazole

Product NDC
63629-1388
11-digit product format
636291388
Labeler code
63629
Product ID
63629-1388_e2a4bade-0163-4eed-8887-2fa27de3e0b8
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
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
Rxcui314106

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
63629-1388-02020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-12020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-22020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-32020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-42020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-52020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-62020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-72020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-82020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-92020-02-25C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-02020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-12020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-22020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-32020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-42020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-52020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-62020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-72020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-82020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP
63629-1388-92020-01-31C16284748780-19d75b9d0-c73f-f424-e053-dadaa90a57ceMetronidazole Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1388-0Metronidazole7 in 1 BOTTLE, PLASTICTABLET, FILM COATED7103
63629-1388-1Metronidazole21 in 1 BOTTLE, PLASTICTABLET, FILM COATED21103
63629-1388-2Metronidazole30 in 1 BOTTLE, PLASTICTABLET, FILM COATED30103
63629-1388-3Metronidazole20 in 1 BOTTLE, PLASTICTABLET, FILM COATED20103
63629-1388-4Metronidazole60 in 1 BOTTLE, PLASTICTABLET, FILM COATED60103
63629-1388-5Metronidazole28 in 1 BOTTLE, PLASTICTABLET, FILM COATED28103
63629-1388-6Metronidazole14 in 1 BOTTLE, PLASTICTABLET, FILM COATED14103
63629-1388-7Metronidazole40 in 1 BOTTLE, PLASTICTABLET, FILM COATED40103
63629-1388-8Metronidazole42 in 1 BOTTLE, PLASTICTABLET, FILM COATED42103
63629-1388-9Metronidazole56 in 1 BOTTLE, PLASTICTABLET, FILM COATED56103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1388-1EA - Each63629-1388a96fa1d7-905e-47f0-a6c2-14e131a855d712012-07-24
63629-1388-2EA - Each63629-13882eed6c9b-bb38-4258-be75-d5aa17aad79312012-07-24
63629-1388-3EA - Each63629-138857b17b18-2119-46a9-9d57-3660518a1a3212012-07-24
63629-1388-4EA - Each63629-1388cca03fc3-bd02-43d2-8ac6-56c1302cf51e12012-07-24
63629-1388-5EA - Each63629-13880c1e4f0d-9b49-4d80-a208-b6ae1bcee97612012-07-24
63629-1388-6EA - Each63629-1388ddf767cd-a331-40dc-b0a4-c9047034f1de12012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1388METRONIDAZOLE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20240910_8e1f507b-22fa-4033-9b3e-5435f20ace66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSN8e1f507b-22fa-4033-9b3e-5435f20ace66103
314106metronidazole 250 MG Oral TabletSCD8e1f507b-22fa-4033-9b3e-5435f20ace66103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1388-0636291388007 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-0) 2017-09-140000-00-00NoNoCurrent
63629-1388-16362913880121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-1) 2024-09-040000-00-00NoNoCurrent
63629-1388-26362913880230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-2) 2024-09-040000-00-00NoNoCurrent
63629-1388-36362913880320 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-3) 2024-09-040000-00-00NoNoCurrent
63629-1388-46362913880460 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-4) 2024-09-040000-00-00NoNoCurrent
63629-1388-56362913880528 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-5) 2024-09-040000-00-00NoNoCurrent
63629-1388-66362913880614 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-6) 2024-09-040000-00-00NoNoCurrent
63629-1388-76362913880740 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-7) 2024-09-040000-00-00NoNoCurrent
63629-1388-86362913880842 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-8) 2018-03-060000-00-00NoNoCurrent
63629-1388-96362913880956 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1388-9) 2024-09-040000-00-00NoNoCurrent