FDA.reportPublic FDA data

Metronidazole

Product NDC
52959-102
11-digit product format
529590102
Labeler code
52959
Product ID
52959-102_9a58a7ae-3045-4b63-bd19-97f74582edc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA070033
Marketing category
ANDA
Marketing start
2011-10-07
Marketing end
0000-00-00
Substance
METRONIDAZOLE
Active strength
500 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
52959-102-042019-11-13C16284748780-197449f38-d313-f6ea-e053-dbdaa90aa703METRONIDAZOLE TABLETS USP
52959-102-082019-11-13C16284748780-197449f38-d313-f6ea-e053-dbdaa90aa703METRONIDAZOLE TABLETS USP
52959-102-142019-11-13C16284748780-197449f38-d313-f6ea-e053-dbdaa90aa703METRONIDAZOLE TABLETS USP
52959-102-152019-11-13C16284748780-197449f38-d313-f6ea-e053-dbdaa90aa703METRONIDAZOLE TABLETS USP
52959-102-202019-11-13C16284748780-197449f38-d313-f6ea-e053-dbdaa90aa703METRONIDAZOLE TABLETS USP
52959-102-212019-11-13C16284748780-197449f38-d313-f6ea-e053-dbdaa90aa703METRONIDAZOLE TABLETS USP
52959-102-282019-11-13C16284748780-197449f38-d313-f6ea-e053-dbdaa90aa703METRONIDAZOLE TABLETS USP
52959-102-302019-11-13C16284748780-197449f38-d313-f6ea-e053-dbdaa90aa703METRONIDAZOLE TABLETS USP
52959-102-422019-11-13C16284748780-197449f38-d313-f6ea-e053-dbdaa90aa703METRONIDAZOLE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-102-04Metronidazole4 in 1 BOTTLETABLET41
52959-102-08Metronidazole8 in 1 BOTTLETABLET81
52959-102-14Metronidazole14 in 1 BOTTLETABLET141
52959-102-15Metronidazole15 in 1 BOTTLETABLET151
52959-102-20Metronidazole20 in 1 BOTTLETABLET201
52959-102-21Metronidazole21 in 1 BOTTLETABLET211
52959-102-28Metronidazole28 in 1 BOTTLETABLET281
52959-102-30Metronidazole30 in 1 BOTTLETABLET301
52959-102-42Metronidazole42 in 1 BOTTLETABLET421

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-102-04EA - Each52959-10246e9119e-7439-4b82-8de8-0b12c1b2773b12012-07-24
52959-102-08EA - Each52959-102aca4f545-271d-4690-8e5a-920aff625cdf12012-07-24
52959-102-14EA - Each52959-10210529951-110e-427e-b4f5-b0e43a28d1fb12012-07-24
52959-102-15EA - Each52959-10281315eae-7a75-4461-a5d9-fdf17e227c0b12012-07-24
52959-102-20EA - Each52959-102e9f9ecb8-07b5-4c66-88ac-52930be1b81112012-07-24
52959-102-21EA - Each52959-102027c72de-a3d4-43b0-a5a9-028a0e4bd57812012-07-24
52959-102-28EA - Each52959-10228a3e7e0-cdc1-4330-aa47-655192b53cfd12012-07-24
52959-102-30EA - Each52959-102a3725c54-ea16-4336-a4e8-5b3c5935a20a12012-07-24
52959-102-42EA - Each52959-102084f8e7a-75f5-4dc7-9acd-59c9870df8ba12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]1
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]1
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAMETRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-102METRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 9 package rows20111212_d552db0a-959c-4ad9-ab65-d7cc541baf7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSNd552db0a-959c-4ad9-ab65-d7cc541baf7e1
311681metroNIDAZOLE 500 MG Oral TabletPSNd552db0a-959c-4ad9-ab65-d7cc541baf7e1
314106metronidazole 250 MG Oral TabletSCDd552db0a-959c-4ad9-ab65-d7cc541baf7e1
311681metronidazole 500 MG Oral TabletSCDd552db0a-959c-4ad9-ab65-d7cc541baf7e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-102-04529590102044 in 1 BOTTLEHistorical
52959-102-08529590102088 in 1 BOTTLEHistorical
52959-102-145295901021414 in 1 BOTTLEHistorical
52959-102-155295901021515 in 1 BOTTLEHistorical
52959-102-205295901022020 in 1 BOTTLEHistorical
52959-102-215295901022121 in 1 BOTTLEHistorical
52959-102-285295901022828 in 1 BOTTLEHistorical
52959-102-305295901023030 in 1 BOTTLEHistorical
52959-102-425295901024242 in 1 BOTTLEHistorical