Metronidazole

Product NDC
43063-738
11-digit product format
430630738
Labeler code
43063
Product ID
43063-738_dea992e7-93ac-6d4c-e053-2995a90acaf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx 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
2023-12-31
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-738METRONIDAZOLE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]25Legacy NDC20240820_d72fb3ee-a668-4bd6-b4b0-8db43520597c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-738-04430630738044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-738-04) 2017-02-090000-00-00NoNoCurrent
43063-738-06430630738066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-738-06) 2017-07-190000-00-00NoNoCurrent
43063-738-09430630738099 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-738-09) 2017-02-030000-00-00NoNoCurrent
43063-738-144306307381414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-738-14) 2017-01-270000-00-00NoNoCurrent
43063-738-214306307382121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-738-21) 2017-02-160000-00-00NoNoCurrent
43063-738-284306307382828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-738-28) 2017-03-130000-00-00NoNoCurrent
43063-738-304306307383030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-738-30) 2017-04-190000-00-00NoNoCurrent
43063-738-79430630738791 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-738-79) 2017-02-090000-00-00NoNoCurrent