FDA.reportPublic FDA data

Metronidazole

Product NDC
0338-1055
11-digit product format
003381055
Labeler code
0338
Product ID
0338-1055_7841a410-43a9-4c79-acee-b831b42da8a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA018657
Marketing category
NDA
Marketing start
1981-12-24
Substance
METRONIDAZOLE
Active strength
500 mg/100mL
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINERMETRONIDAZOLE500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018657-001AP

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 22:54:322026-06N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N018657-001AP1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLECivica, Inc.902ab25b-d493-495a-884e-96b080e9f72d2025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018657
application number: NDA018657
MetronidazoleMETRONIDAZOLEBaxter Healthcare Corporationd2112f37-5080-4a19-bcc3-6386b49abe1d2025-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018657
application number: NDA018657
ndc (product): 0338-1055
MetronidazoleMETRONIDAZOLEBaxter Healthcare Corporation9d762edb-12ac-429d-b1f0-7af5d3b909d42025-06-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 018657
application number: NDA018657

Additional Listing Data#

Finished product
Yes
Brand name base
Metronidazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRONIDAZOLE500 mg/100mL

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
311683Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d2112f37-5080-4a19-bcc3-6386b49abe1dAvailable 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
0338-1055-48Metronidazole100 mL in 1 BAGINJECTION, SOLUTION10024
0338-1055-48Metronidazole24 in 1 CARTONINJECTION, SOLUTION2424

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-1055-48ML - Milliliter0338-10554c57d0b2-48d6-4441-918f-5c695e2e983512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]8
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]8
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMETRONIDAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]8
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMETRONIDAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]8
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74METRONIDAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]8
WATERINACTIVE INGREDIENT059QF0KO0RMETRONIDAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-1055METRONIDAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]22Current NDC, Legacy NDC, 2 package rows20250507_d2112f37-5080-4a19-bcc3-6386b49abe1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311683metroNIDAZOLE 500 MG in 100 ML InjectionPSNd2112f37-5080-4a19-bcc3-6386b49abe1d24
311683100 ML metronidazole 5 MG/ML InjectionSCDd2112f37-5080-4a19-bcc3-6386b49abe1d24
311683metronidazole 500 MG per 100 ML InjectionSYd2112f37-5080-4a19-bcc3-6386b49abe1d24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-1055-480033810554824 BAG in 1 CARTON (0338-1055-48) / 100 mL in 1 BAG24 bag1981-12-240000-00-00NoNoCurrent