Metronidazole

Product NDC
53002-2470
11-digit product format
530022470
Labeler code
53002
Product ID
53002-2470_4e7603fe-84b9-434e-a8cd-5b71cc91f58b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA203458
Marketing category
ANDA
Marketing start
2014-06-01
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
2021-12-31
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
53002-2470-12025-01-30C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-22025-01-30C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-32025-01-30C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-42025-01-30C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-12023-06-08C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-22023-06-08C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-32023-06-08C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-42023-06-08C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-12023-01-30C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-22023-01-30C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-32023-01-30C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-42023-01-30C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-12020-12-15C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-22020-12-15C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-32020-12-15C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-42020-12-15C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-12020-01-31C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-22020-01-31C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-32020-01-31C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP
53002-2470-42020-01-31C16284748780-19d75b9d0-c748-f424-e053-dadaa90a57ceMetronidazole Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2470-1Metronidazole10 in 1 BOTTLETABLET, FILM COATED105
53002-2470-2Metronidazole14 in 1 BOTTLETABLET, FILM COATED145
53002-2470-3Metronidazole20 in 1 BOTTLETABLET, FILM COATED205
53002-2470-4Metronidazole28 in 1 BOTTLETABLET, FILM COATED285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2470METRONIDAZOLE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 4 package rows20230609_b8fd8441-624d-4600-b1ca-17d5be73b203.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSNb8fd8441-624d-4600-b1ca-17d5be73b2035
311681metronidazole 500 MG Oral TabletSCDb8fd8441-624d-4600-b1ca-17d5be73b2035

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-2470-15300224700110 TABLET, FILM COATED in 1 BOTTLE (53002-2470-1) 2017-10-010000-00-00NoNoCurrent
53002-2470-25300224700214 TABLET, FILM COATED in 1 BOTTLE (53002-2470-2) 2017-10-010000-00-00NoNoCurrent
53002-2470-35300224700320 TABLET, FILM COATED in 1 BOTTLE (53002-2470-3) 2017-10-010000-00-00NoNoCurrent
53002-2470-45300224700428 TABLET, FILM COATED in 1 BOTTLE (53002-2470-4) 2017-10-010000-00-00NoNoCurrent