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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203458-001METRONIDAZOLEMETRONIDAZOLE250MGTABLET / ORALAB2014-01-22
A203458-002METRONIDAZOLEMETRONIDAZOLE500MGTABLET / ORALAB2014-01-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203458-001AB
A203458-002AB

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 22:54:322026-06A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-22a50c72e98297…
2026-08-01 22:54:322026-06A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203458-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A203458-002AB1a50c72e98297…

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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.2f7d84d4-1085-4243-be88-442eecb852052026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.cfeab9e3-58b9-4890-9185-11b62904e2af2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.cbee69e8-029c-49d2-89cd-f504b8e0ac282026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.3e0a14f1-961b-4722-bfea-aafcc5d7706c2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.49bed450-7fa8-401c-8c8c-afc1c61d473a2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.3c0ebb00-a0ae-4f64-9bfc-de01193191e82026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLECoupler LLC545f2900-745c-c33c-e063-6294a90a5e4f2026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLECoupler LLC509c8d03-e199-8154-e063-6394a90afddc2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLESt. Mary's Medical Park Pharmacy60689b96-cb58-925a-e053-2a91aa0a32a32026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack1277591d-ccf4-428a-b647-cb1ef3fbf5612026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLEA-S Medication Solutions02046a22-a5eb-4bb7-bec7-e5a2aa55e1422026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLEBluePoint Laboratories3cf021b6-5794-4a86-b09d-bece0ba8b3022026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
METRONIDAZOLEMETRONIDAZOLEDirect_Rx90a5acb3-f8cc-1e82-e053-2995a90a4e972026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLEProficient Rx LPa56c2842-8ad4-4396-8eb6-cbcd1629fcb12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLENuCare Pharmaceuticals, Inc.4040db14-750f-6d20-e054-00144ff8d46c2025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLERedpharm Drug32523df9-8c47-200f-e063-6294a90ac8902025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLEA-S Medication Solutions60ad086d-6f54-4134-b608-53a6ff571ff82025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLEA-S Medication Solutions2a5af710-dbf7-41c1-9b3a-35e69b3fa4ab2025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLEA-S Medication Solutions9a18debb-3bb8-4b23-949b-aaa0f3b621912025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLEPD-Rx Pharmaceuticals, Inc.353b7f5b-4bbc-4ec9-84ba-d82656ea18112025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
ndc (product): 43063-719

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
140QMO216EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
314106Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
353b7f5b-4bbc-4ec9-84ba-d82656ea1811Available on FDA.report

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