Metronidazole

Product NDC
72789-011
11-digit product format
727890011
Labeler code
72789
Product ID
72789-011_4030f387-f074-830f-e063-6394a90ac448
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA079067
Marketing category
ANDA
Marketing start
2016-12-01
Substance
METRONIDAZOLE
Active strength
500 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
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
72789-011-04Metronidazole4 in 1 BOTTLE, PLASTICTABLET418
72789-011-14Metronidazole14 in 1 BOTTLE, PLASTICTABLET1418

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-011-04EA - Each72789-01191a1973e-f999-4ecd-ab94-bcb3392368e212020-02-13
72789-011-14EA - Each72789-011503fa3a7-aceb-41ae-95e8-4e77ea51495512019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-011METRONIDAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 2 package rows20240829_b85bdc1f-1ffb-40d5-a407-e8de2891996d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSNb85bdc1f-1ffb-40d5-a407-e8de2891996d18
311681metronidazole 500 MG Oral TabletSCDb85bdc1f-1ffb-40d5-a407-e8de2891996d18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-011-04727890011044 TABLET in 1 BOTTLE, PLASTIC (72789-011-04) 4 tablet2019-08-200000-00-00NoNoCurrent
72789-011-147278900111414 TABLET in 1 BOTTLE, PLASTIC (72789-011-14) 14 tablet2020-01-130000-00-00NoNoCurrent