FDA.reportPublic FDA data

metronidazole

Product NDC
72789-195
11-digit product format
727890195
Labeler code
72789
Product ID
72789-195_40abd4b1-5378-c5b0-e063-6394a90af09d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA206560
Marketing category
ANDA
Marketing start
2019-02-23
Substance
METRONIDAZOLE
Active strength
250 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
metronidazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRONIDAZOLE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii140QMO216E
Rxcui314106

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
a5070875-62bb-61e1-fd46-8f7054197a40Product name820180215
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-195-06metronidazole6 in 1 BOTTLE, PLASTICTABLET613
72789-195-21metronidazole21 in 1 BOTTLE, PLASTICTABLET2113
72789-195-30metronidazole30 in 1 BOTTLE, PLASTICTABLET3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-195-06EA - Each72789-19533e667c3-6f53-45b3-a9e8-aa4aa32bf30e12022-01-06
72789-195-21EA - Each72789-195a54c4624-d105-420a-8c42-20d28bd77a3c12022-01-06
72789-195-30EA - Each72789-1950581fd11-e381-4a82-a92e-7b2735b10e2912021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-195METRONIDAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 3 package rows20240906_8f1de4ca-a005-4ca9-a43a-380429c80d6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSN8f1de4ca-a005-4ca9-a43a-380429c80d6f13
314106metronidazole 250 MG Oral TabletSCD8f1de4ca-a005-4ca9-a43a-380429c80d6f13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-195-06727890195066 TABLET in 1 BOTTLE, PLASTIC (72789-195-06) 6 tablet2021-10-290000-00-00NoNoCurrent
72789-195-217278901952121 TABLET in 1 BOTTLE, PLASTIC (72789-195-21) 21 tablet2021-06-300000-00-00NoNoCurrent
72789-195-307278901953030 TABLET in 1 BOTTLE, PLASTIC (72789-195-30) 30 tablet2021-06-300000-00-00NoNoCurrent