FDA.reportPublic FDA data

Metronidazole

Product NDC
54348-740
11-digit product format
543480740
Labeler code
54348
Product ID
54348-740_ea93abaf-cd17-a842-e053-2995a90a8fb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METRONIDAZOLE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PharmPak, Inc.
Application
ANDA203458
Marketing category
ANDA
Marketing start
2019-07-10
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
54348-740-00Metronidazole1 in 1 BOTTLETABLET, FILM COATED12
54348-740-00Metronidazole1 in 1 BOXTABLET, FILM COATED12
54348-740-04Metronidazole1 in 1 BOXTABLET, FILM COATED12
54348-740-04Metronidazole4 in 1 BOTTLETABLET, FILM COATED42
54348-740-09Metronidazole9 in 1 BOTTLETABLET, FILM COATED92
54348-740-09Metronidazole1 in 1 BOXTABLET, FILM COATED12
54348-740-14Metronidazole1 in 1 BOXTABLET, FILM COATED12
54348-740-14Metronidazole14 in 1 BOTTLETABLET, FILM COATED142
54348-740-28Metronidazole28 in 1 BOTTLETABLET, FILM COATED282
54348-740-28Metronidazole1 in 1 BOXTABLET, FILM COATED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54348-740-04EA - Each54348-740305c0fc7-e083-4d0d-bc98-da0586925d2912019-09-05
54348-740-14EA - Each54348-740075a6d5a-2cb2-45d6-855d-4d12948354ca12026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54348-740METRONIDAZOLE TABLET, FILM COATED [PHARMPAK, INC.]2Current NDC, Legacy NDC, 10 package rows20221011_be23affb-5b30-40ee-b0b5-829666bafaeb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSNbe23affb-5b30-40ee-b0b5-829666bafaeb2
311681metronidazole 500 MG Oral TabletSCDbe23affb-5b30-40ee-b0b5-829666bafaeb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54348-740-00543480740001 BOTTLE in 1 BOX (54348-740-00) / 1 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent
54348-740-04543480740041 BOTTLE in 1 BOX (54348-740-04) / 4 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent
54348-740-09543480740091 BOTTLE in 1 BOX (54348-740-09) / 9 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent
54348-740-14543480740141 BOTTLE in 1 BOX (54348-740-14) / 14 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent
54348-740-28543480740281 BOTTLE in 1 BOX (54348-740-28) / 28 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent