FDA.reportPublic FDA data

Metronidazole

Product NDC
33261-384
11-digit product format
332610384
Labeler code
33261
Product ID
33261-384_351fe213-7c9c-4d7e-a68e-3d6b84c663ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA070044
Marketing category
ANDA
Marketing start
2011-08-22
Marketing end
0000-00-00
Substance
METRONIDAZOLE
Active strength
500 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
33261-384-142020-01-31C16284748780-19d75b9d0-4984-f424-e053-dadaa90a57ceMETRONIDAZOLE TABLETS USP 250 mg AND 500 mg Revised: April 2013 Rx only
33261-384-202020-01-31C16284748780-19d75b9d0-4984-f424-e053-dadaa90a57ceMETRONIDAZOLE TABLETS USP 250 mg AND 500 mg Revised: April 2013 Rx only
33261-384-212020-01-31C16284748780-19d75b9d0-4984-f424-e053-dadaa90a57ceMETRONIDAZOLE TABLETS USP 250 mg AND 500 mg Revised: April 2013 Rx only
33261-384-302020-01-31C16284748780-19d75b9d0-4984-f424-e053-dadaa90a57ceMETRONIDAZOLE TABLETS USP 250 mg AND 500 mg Revised: April 2013 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-384-14Metronidazole14 in 1 BOTTLE, PLASTICTABLET141
33261-384-20Metronidazole20 in 1 BOTTLE, PLASTICTABLET201
33261-384-21Metronidazole21 in 1 BOTTLE, PLASTICTABLET211
33261-384-30Metronidazole30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-384-14EA - Each33261-384f06afdd3-739f-4bc9-a883-a0bc375e320b12015-10-02
33261-384-20EA - Each33261-3849b150ded-0083-4f75-bbdc-e98145798e9112015-10-02
33261-384-21EA - Each33261-3849557eab8-dd8e-4a5a-bce6-de48d0625b1312016-09-02
33261-384-30EA - Each33261-384ee838d60-b2ee-4bbf-b678-30715e5c2ece12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETRONIDAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMETRONIDAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METRONIDAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMETRONIDAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-384METRONIDAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20140128_3cd88295-fbca-4b43-8ec4-1bfebb485668.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSN3cd88295-fbca-4b43-8ec4-1bfebb4856681
311681metronidazole 500 MG Oral TabletSCD3cd88295-fbca-4b43-8ec4-1bfebb4856681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-384-143326103841414 in 1 BOTTLE, PLASTICHistorical
33261-384-203326103842020 in 1 BOTTLE, PLASTICHistorical
33261-384-213326103842121 in 1 BOTTLE, PLASTICHistorical
33261-384-303326103843030 in 1 BOTTLE, PLASTICHistorical