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 42.

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018657-001FLAGYL I.V. RTU IN PLASTIC CONTAINER500MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018657-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018657-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018657-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018657-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018657-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018657-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018657-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018657-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018657-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018657-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018657-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018657-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018657-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018657-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018657-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018657-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018657-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018657-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018657-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018657-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018657-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018657-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N018657-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018657-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018657-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018657-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N018657-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018657-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018657-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018657-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018657-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018657-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018657-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018657-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018657-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018657-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018657-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018657-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018657-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018657-001AP1e64feba35796…

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#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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

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