FDA.reportPublic FDA data

Metronidazole

Product NDC
0338-9541
11-digit product format
003389541
Labeler code
0338
Product ID
0338-9541_fe7d4a4d-927d-4792-a171-1c7c0e042fc2
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

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 Identifiers#

Field, Values table
FieldValues
Unii140QMO216E
Rxcui311683

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
0338-9541-24Metronidazole24 in 1 CARTONINJECTION, SOLUTION2416
0338-9541-24Metronidazole100 mL in 1 BAGINJECTION, SOLUTION10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9541-24ML - Milliliter0338-9541214da49c-3d59-4e6b-a259-f8296b88760b12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]2
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMETRONIDAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMETRONIDAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74METRONIDAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RMETRONIDAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-9541METRONIDAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14Current NDC, Legacy NDC, 2 package rows20250515_9d762edb-12ac-429d-b1f0-7af5d3b909d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311683metroNIDAZOLE 500 MG in 100 ML InjectionPSN9d762edb-12ac-429d-b1f0-7af5d3b909d416
311683100 ML metronidazole 5 MG/ML InjectionSCD9d762edb-12ac-429d-b1f0-7af5d3b909d416
311683metronidazole 500 MG per 100 ML InjectionSY9d762edb-12ac-429d-b1f0-7af5d3b909d416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-9541-240033895412424 BAG in 1 CARTON (0338-9541-24) / 100 mL in 1 BAG24 bag1981-12-240000-00-00NoNoCurrent