Metronidazole

Product NDC
55700-298
11-digit product format
557000298
Labeler code
55700
Product ID
55700-298_3a93841b-bd44-407f-a18d-6bee13438b7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products LLC
Application
ANDA203458
Marketing category
ANDA
Marketing start
2014-06-01
Marketing end
2027-03-31
Substance
METRONIDAZOLE
Active strength
500 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metronidazole

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRONIDAZOLE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii140QMO216E
Rxcui311681

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55700-298-04Metronidazole4 in 1 BOTTLE, PLASTICTABLET, FILM COATED47
55700-298-14Metronidazole14 in 1 BOTTLE, PLASTICTABLET, FILM COATED147
55700-298-20Metronidazole20 in 1 BOTTLE, PLASTICTABLET, FILM COATED207
55700-298-21Metronidazole21 in 1 BOTTLE, PLASTICTABLET, FILM COATED217
55700-298-30Metronidazole30 in 1 BOTTLE, PLASTICTABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-298-04EA - Each55700-298d23ff314-48e1-4b81-a60f-22921c3a4b2b12016-06-14
55700-298-14EA - Each55700-298c561ab79-b067-43d0-89ed-f86f81d93da712016-06-14
55700-298-20EA - Each55700-29885d0a59c-e383-412c-a44f-7c14a26b69cb12016-06-14
55700-298-21EA - Each55700-29884d42337-7cc8-490d-9c1b-0ada7c2f104612016-06-14
55700-298-30EA - Each55700-2987fb024b7-ea5f-4dc6-b397-af0e24fd018912016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-298METRONIDAZOLE TABLET, FILM COATED [QUALITY CARE PRODUCTS LLC]7Current NDC, Legacy NDC, 5 package rows20241219_0d8125d6-173f-4498-85a9-a1323c7a0e42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSN0d8125d6-173f-4498-85a9-a1323c7a0e427
311681metronidazole 500 MG Oral TabletSCD0d8125d6-173f-4498-85a9-a1323c7a0e427

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-298-04557000298044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-298-04) 2015-09-212027-03-31NoNoCurrent
55700-298-145570002981414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-298-14) 2015-09-212027-03-31NoNoCurrent
55700-298-205570002982020 in 1 BOTTLE, PLASTICHistorical
55700-298-215570002982121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-298-21) 2015-09-212027-03-31NoNoCurrent
55700-298-305570002983030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-298-30) 2015-09-210000-00-00NoNoCurrent