FDA.reportPublic FDA data

Metronidazole

Product NDC
63187-827
11-digit product format
631870827
Labeler code
63187
Product ID
63187-827_dd1f4531-7376-4eb7-9da6-69c1444a9ec3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203458
Marketing category
ANDA
Marketing start
2014-06-01
Substance
METRONIDAZOLE
Active strength
500 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metronidazole
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-827-04Metronidazole04 in 1 BOTTLE, PLASTICTABLET, FILM COATED047
63187-827-14Metronidazole14 in 1 BOTTLE, PLASTICTABLET, FILM COATED147
63187-827-21Metronidazole21 in 1 BOTTLE, PLASTICTABLET, FILM COATED217
63187-827-28Metronidazole28 in 1 BOTTLE, PLASTICTABLET, FILM COATED287
63187-827-30Metronidazole30 in 1 BOTTLE, PLASTICTABLET, FILM COATED307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-827METRONIDAZOLE TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 5 package rows20240805_a56c2842-8ad4-4396-8eb6-cbcd1629fcb1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSNa56c2842-8ad4-4396-8eb6-cbcd1629fcb17
311681metronidazole 500 MG Oral TabletSCDa56c2842-8ad4-4396-8eb6-cbcd1629fcb17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-827-04631870827044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-04) 2017-05-010000-00-00NoNoCurrent
63187-827-146318708271414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-14) 2014-06-010000-00-00NoNoCurrent
63187-827-216318708272121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-21) 2014-06-010000-00-00NoNoCurrent
63187-827-286318708272828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-28) 2026-01-28NoNoCurrent
63187-827-306318708273030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-30) 2014-06-010000-00-00NoNoCurrent
63187-827-606318708276060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-60) 2014-06-010000-00-00NoNoCurrent
63187-827-906318708279090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-90) 2017-04-030000-00-00NoNoCurrent