FDA.reportPublic FDA data

Metronidazole

Product NDC
29300-227
11-digit product format
293000227
Labeler code
29300
Product ID
29300-227_afe0fa12-6438-4bd6-9a71-1f248bc9c54d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
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
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, 314106

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
29300-227-01Metronidazole100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10016
29300-227-05Metronidazole500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50016
29300-227-10Metronidazole1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100016
29300-227-46Metronidazole50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-227-01EA - Each29300-227160cf9d9-97d8-4ad5-a4de-879e29b13ee312014-09-03
29300-227-05EA - Each29300-227b7e75f34-70c0-49de-b782-14be6109ac8812014-09-03
29300-227-46EA - Each29300-22741bf7bbe-bf53-4660-98dc-56a3c9acf9e612014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]3
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PMETRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]3
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]3
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]3
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MMETRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMETRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]3
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [DIRECT RX]2
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [DIRECT RX]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETRONIDAZOLE TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [DIRECT RX]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMETRONIDAZOLE TABLET [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [DIRECT RX]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METRONIDAZOLE TABLET [DIRECT RX]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMETRONIDAZOLE TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-227METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]16Current NDC, Legacy NDC, 4 package rows20240806_9219588b-0a99-40b9-bdd4-ced6d6efebed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSN1277591d-ccf4-428a-b647-cb1ef3fbf561100
311681metroNIDAZOLE 500 MG Oral TabletPSNdaee5e69-aa86-470b-81b7-3074d27fc847100
311681metronidazole 500 MG Oral TabletSCDdaee5e69-aa86-470b-81b7-3074d27fc847100
311681metronidazole 500 MG Oral TabletSCD1277591d-ccf4-428a-b647-cb1ef3fbf561100
311681metroNIDAZOLE 500 MG Oral TabletPSN3c0ebb00-a0ae-4f64-9bfc-de01193191e832
311681metronidazole 500 MG Oral TabletSCD3c0ebb00-a0ae-4f64-9bfc-de01193191e832
311681metroNIDAZOLE 500 MG Oral TabletPSN49bed450-7fa8-401c-8c8c-afc1c61d473a29
311681metronidazole 500 MG Oral TabletSCD49bed450-7fa8-401c-8c8c-afc1c61d473a29
311681metroNIDAZOLE 500 MG Oral TabletPSN9a18debb-3bb8-4b23-949b-aaa0f3b6219126
311681metronidazole 500 MG Oral TabletSCD9a18debb-3bb8-4b23-949b-aaa0f3b6219126
311681metroNIDAZOLE 500 MG Oral TabletPSN60ad086d-6f54-4134-b608-53a6ff571ff821
311681metronidazole 500 MG Oral TabletSCD60ad086d-6f54-4134-b608-53a6ff571ff821
311681metroNIDAZOLE 500 MG Oral TabletPSN2a5af710-dbf7-41c1-9b3a-35e69b3fa4ab18
311681metroNIDAZOLE 500 MG Oral TabletPSN4cdd7ac5-a52c-4766-afeb-1b5e567a328c18
311681metronidazole 500 MG Oral TabletSCD2a5af710-dbf7-41c1-9b3a-35e69b3fa4ab18
311681metronidazole 500 MG Oral TabletSCD4cdd7ac5-a52c-4766-afeb-1b5e567a328c18
314106metroNIDAZOLE 250 MG Oral TabletPSN9219588b-0a99-40b9-bdd4-ced6d6efebed16
311681metroNIDAZOLE 500 MG Oral TabletPSN9219588b-0a99-40b9-bdd4-ced6d6efebed16
314106metronidazole 250 MG Oral TabletSCD9219588b-0a99-40b9-bdd4-ced6d6efebed16
311681metronidazole 500 MG Oral TabletSCD9219588b-0a99-40b9-bdd4-ced6d6efebed16
311681metroNIDAZOLE 500 MG Oral TabletPSN2f7d84d4-1085-4243-be88-442eecb8520512
311681metronidazole 500 MG Oral TabletSCD2f7d84d4-1085-4243-be88-442eecb8520512
311681metroNIDAZOLE 500 MG Oral TabletPSN48836437-c2c2-1ea2-e054-00144ff8d46c10
311681metroNIDAZOLE 500 MG Oral TabletPSNcdd942a1-fb3b-4912-bd3f-8aef451e6a3c10
311681metronidazole 500 MG Oral TabletSCD48836437-c2c2-1ea2-e054-00144ff8d46c10
311681metronidazole 500 MG Oral TabletSCDcdd942a1-fb3b-4912-bd3f-8aef451e6a3c10
311681metroNIDAZOLE 500 MG Oral TabletPSN4040db14-750f-6d20-e054-00144ff8d46c8
311681metronidazole 500 MG Oral TabletSCD4040db14-750f-6d20-e054-00144ff8d46c8
311681metroNIDAZOLE 500 MG Oral TabletPSN6e5ea18b-7ccc-08fc-e053-2991aa0a79447
311681metroNIDAZOLE 500 MG Oral TabletPSN60689b96-cb58-925a-e053-2a91aa0a32a37
311681metroNIDAZOLE 500 MG Oral TabletPSN0d8125d6-173f-4498-85a9-a1323c7a0e427
311681metroNIDAZOLE 500 MG Oral TabletPSNa56c2842-8ad4-4396-8eb6-cbcd1629fcb17
311681metronidazole 500 MG Oral TabletSCDa56c2842-8ad4-4396-8eb6-cbcd1629fcb17
311681metronidazole 500 MG Oral TabletSCD60689b96-cb58-925a-e053-2a91aa0a32a37
311681metronidazole 500 MG Oral TabletSCD0d8125d6-173f-4498-85a9-a1323c7a0e427
311681metronidazole 500 MG Oral TabletSCD6e5ea18b-7ccc-08fc-e053-2991aa0a79447
311681metroNIDAZOLE 500 MG Oral TabletPSNfb306ef2-5203-4034-b699-b8657c7ef2576
311681metroNIDAZOLE 500 MG Oral TabletPSN90a5acb3-f8cc-1e82-e053-2995a90a4e976
311681metroNIDAZOLE 500 MG Oral TabletPSN1abb2827-67e4-43c0-9762-8261f480fc3a6
311681metronidazole 500 MG Oral TabletSCD90a5acb3-f8cc-1e82-e053-2995a90a4e976
311681metronidazole 500 MG Oral TabletSCDfb306ef2-5203-4034-b699-b8657c7ef2576
311681metronidazole 500 MG Oral TabletSCD1abb2827-67e4-43c0-9762-8261f480fc3a6
311681metroNIDAZOLE 500 MG Oral TabletPSNb8fd8441-624d-4600-b1ca-17d5be73b2035
311681metroNIDAZOLE 500 MG Oral TabletPSN4fbe2b3f-4c6f-43b7-e054-00144ff8d46c5
311681metronidazole 500 MG Oral TabletSCD4fbe2b3f-4c6f-43b7-e054-00144ff8d46c5
311681metronidazole 500 MG Oral TabletSCDb8fd8441-624d-4600-b1ca-17d5be73b2035
311681metroNIDAZOLE 500 MG Oral TabletPSNb1d13c9f-cf8e-4646-e053-2a95a90a4a354
311681metronidazole 500 MG Oral TabletSCDb1d13c9f-cf8e-4646-e053-2a95a90a4a354
311681metroNIDAZOLE 500 MG Oral TabletPSN90a6139b-66e8-7754-e053-2a95a90af8153
311681metronidazole 500 MG Oral TabletSCD90a6139b-66e8-7754-e053-2a95a90af8153
311681metroNIDAZOLE 500 MG Oral TabletPSNbe23affb-5b30-40ee-b0b5-829666bafaeb2
311681metroNIDAZOLE 500 MG Oral TabletPSNcbee69e8-029c-49d2-89cd-f504b8e0ac282
311681metroNIDAZOLE 500 MG Oral TabletPSN8b0f1827-57cd-ed40-e053-2995a90a06302
311681metroNIDAZOLE 500 MG Oral TabletPSN932677ef-0123-4481-ba11-8bd8065c653b2
311681metroNIDAZOLE 500 MG Oral TabletPSN90a56d96-a454-3fb3-e053-2a95a90ad2912
311681metroNIDAZOLE 500 MG Oral TabletPSN2783e34b-384d-04af-e054-00144ff8d46c2
311681metronidazole 500 MG Oral TabletSCD932677ef-0123-4481-ba11-8bd8065c653b2
311681metronidazole 500 MG Oral TabletSCDbe23affb-5b30-40ee-b0b5-829666bafaeb2
311681metronidazole 500 MG Oral TabletSCD90a56d96-a454-3fb3-e053-2a95a90ad2912
311681metronidazole 500 MG Oral TabletSCD8b0f1827-57cd-ed40-e053-2995a90a06302
311681metronidazole 500 MG Oral TabletSCDcbee69e8-029c-49d2-89cd-f504b8e0ac282
311681metronidazole 500 MG Oral TabletSCD2783e34b-384d-04af-e054-00144ff8d46c2
311681metroNIDAZOLE 500 MG Oral TabletPSN9adc9cc1-08a1-62b9-e053-2a95a90aee4a1
311681metroNIDAZOLE 500 MG Oral TabletPSN509c8d03-e199-8154-e063-6394a90afddc1
311681metroNIDAZOLE 500 MG Oral TabletPSN08fcd3b0-473a-433d-ae09-0c8a47441fee1
311681metronidazole 500 MG Oral TabletSCD9adc9cc1-08a1-62b9-e053-2a95a90aee4a1
311681metronidazole 500 MG Oral TabletSCD08fcd3b0-473a-433d-ae09-0c8a47441fee1
311681metronidazole 500 MG Oral TabletSCD509c8d03-e199-8154-e063-6394a90afddc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-227-0129300022701100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-227-01) 2014-06-010000-00-00NoNoCurrent
29300-227-0529300022705500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-227-05) 2014-06-010000-00-00NoNoCurrent
29300-227-10293000227101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-227-10) 2014-06-010000-00-00NoNoCurrent
29300-227-462930002274650 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-227-46) 2014-06-010000-00-00NoNoCurrent