FDA.reportPublic FDA data

Metronidazole

Product NDC
0440-1795
11-digit product format
004401795
Labeler code
0440
Product ID
0440-1795_fd60fa16-9bd2-4337-b52f-bf71d6e14714
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA070027
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
METRONIDAZOLE
Active strength
250 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0440-1795IInactivated by FDA2026-07-31
excluded packagepackage0440-17950440-1795-28IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070027-001METRONIDAZOLEMETRONIDAZOLE250MGTABLET / ORALAB1984-11-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A070027-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A070027-001METRONIDAZOLE250MGTABLET / ORALAB1984-11-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A070027-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.ca450fad-0513-4c45-8ea0-1f46bcbf6a362026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070027
application number: ANDA070027
MetronidazoleMETRONIDAZOLEBryant Ranch Prepackea635d05-b3c1-4f49-ace2-d091c20920da2024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070027
application number: ANDA070027
MetronidazoleMETRONIDAZOLETeva Pharmaceuticals USA, Inc.291a45f6-ed27-4dcc-8364-358d086237972024-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070027
application number: ANDA070027
MetronidazoleMETRONIDAZOLEProficient Rx LP205054e1-8172-47dc-931c-a18a60e7e9f02022-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070027
application number: ANDA070027

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
0440-1795-282020-01-31C16284748780-19d75b9d0-8404-f424-e053-dadaa90a57ceMETRONIDAZOLE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-1795-28Metronidazole28 in 1 BOTTLE, PLASTICTABLET281

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-1795-28EA - Each0440-17958c2c5134-6213-4a57-8e44-33806ab24c5312013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAMETRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-1795METRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20130911_5911e8f2-1b3a-4222-b997-d2a1c9a9f535.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSN5911e8f2-1b3a-4222-b997-d2a1c9a9f5351
311681metroNIDAZOLE 500 MG Oral TabletPSN5911e8f2-1b3a-4222-b997-d2a1c9a9f5351
314106metronidazole 250 MG Oral TabletSCD5911e8f2-1b3a-4222-b997-d2a1c9a9f5351
311681metronidazole 500 MG Oral TabletSCD5911e8f2-1b3a-4222-b997-d2a1c9a9f5351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-1795-280044017952828 in 1 BOTTLE, PLASTICHistorical