FDA.reportPublic FDA data

Metronidazole

Product NDC
43063-719
11-digit product format
430630719
Labeler code
43063
Product ID
43063-719_414af257-be78-1935-e063-6394a90a7b1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-719-06Metronidazole6 in 1 BOTTLE, PLASTICTABLET, FILM COATED622
43063-719-21Metronidazole21 in 1 BOTTLE, PLASTICTABLET, FILM COATED2122
43063-719-28Metronidazole28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2822
43063-719-30Metronidazole30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3022
43063-719-56Metronidazole56 in 1 BOTTLE, PLASTICTABLET, FILM COATED5622

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-719-06EA - Each43063-7191f436c0f-9a1f-47ab-a8e1-9a26f7632d2712017-03-06
43063-719-21EA - Each43063-7197238b005-c207-4f1e-a0dd-94bfad32ddc212017-06-15
43063-719-28EA - Each43063-719aa51c53e-5cb0-4cdd-9c75-e7ef41ab75d912017-06-15
43063-719-30EA - Each43063-719123fa14f-f289-4d82-90a8-85d40c4a67c512016-12-07
43063-719-56EA - Each43063-7191bdfbea0-4d05-46bf-8839-d323c61f0a8412018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-719METRONIDAZOLE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 5 package rows20240815_353b7f5b-4bbc-4ec9-84ba-d82656ea1811.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSN353b7f5b-4bbc-4ec9-84ba-d82656ea181122
314106metronidazole 250 MG Oral TabletSCD353b7f5b-4bbc-4ec9-84ba-d82656ea181122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-719-06430630719066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-06) 2016-11-020000-00-00NoNoCurrent
43063-719-214306307192121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-21) 2017-05-010000-00-00NoNoCurrent
43063-719-284306307192828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-28) 2017-05-030000-00-00NoNoCurrent
43063-719-304306307193030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-30) 2016-10-240000-00-00NoNoCurrent
43063-719-564306307195656 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-56) 2018-04-050000-00-00NoNoCurrent