FDA.reportPublic FDA data

metronidazole

Product NDC
68788-7815
11-digit product format
687887815
Labeler code
68788
Product ID
68788-7815_1820c0da-b46b-409a-8e06-98acd1189737
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA206560
Marketing category
ANDA
Marketing start
2020-11-13
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
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
68788-7815-1metronidazole14 in 1 BOTTLETABLET146
68788-7815-2metronidazole21 in 1 BOTTLETABLET216
68788-7815-3metronidazole30 in 1 BOTTLETABLET306
68788-7815-4metronidazole28 in 1 BOTTLETABLET286
68788-7815-5metronidazole56 in 1 BOTTLETABLET566
68788-7815-7metronidazole42 in 1 BOTTLETABLET426

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7815-1EA - Each68788-78151d77dd12-26e0-432b-a9e2-bf9f06ce520312021-01-08
68788-7815-2EA - Each68788-78150eddc696-43ec-4912-892d-700987936dad12021-01-08
68788-7815-3EA - Each68788-78153f38c745-eb46-4360-b00b-8b06275a686612021-01-08
68788-7815-4EA - Each68788-7815c74e66fc-e3f8-48f6-a0d2-a30b454935f812021-01-08
68788-7815-5EA - Each68788-7815724c5717-273d-4461-a6a7-e604d4af887412021-01-08
68788-7815-7EA - Each68788-7815970c1814-2e49-49cb-84bd-cd31e91e965512021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7815METRONIDAZOLE TABLET [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 6 package rows20240719_ab695a3e-1721-491a-97a2-c3f617a8d9fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSNab695a3e-1721-491a-97a2-c3f617a8d9fc6
311681metronidazole 500 MG Oral TabletSCDab695a3e-1721-491a-97a2-c3f617a8d9fc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7815-16878878150114 TABLET in 1 BOTTLE (68788-7815-1) 14 tablet2020-11-130000-00-00NoNoCurrent
68788-7815-26878878150221 TABLET in 1 BOTTLE (68788-7815-2) 21 tablet2020-11-130000-00-00NoNoCurrent
68788-7815-36878878150330 TABLET in 1 BOTTLE (68788-7815-3) 30 tablet2020-11-130000-00-00NoNoCurrent
68788-7815-46878878150428 TABLET in 1 BOTTLE (68788-7815-4) 28 tablet2020-11-130000-00-00NoNoCurrent
68788-7815-56878878150556 TABLET in 1 BOTTLE (68788-7815-5) 56 tablet2020-11-130000-00-00NoNoCurrent
68788-7815-76878878150742 TABLET in 1 BOTTLE (68788-7815-7) 42 tablet2020-11-130000-00-00NoNoCurrent