metronidazole

Product NDC
68071-2409
Requested package NDC
68071-2409-7
11-digit product format
680712409
Labeler code
68071
Product ID
68071-2409_10f6b5cd-3cf8-e2fe-e063-6394a90a690c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA206560
Marketing category
ANDA
Marketing start
2019-02-23
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206560-001METRONIDAZOLEMETRONIDAZOLE250MGTABLET / ORALAB2016-11-16
A206560-002METRONIDAZOLEMETRONIDAZOLE500MGTABLET / ORALAB2016-11-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A206560-001AB
A206560-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-16782e0a99824c…
2021-12-28 21:50 UTC2021-12A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-16782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206560-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206560-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206560-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206560-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206560-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206560-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206560-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206560-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206560-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206560-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206560-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206560-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206560-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206560-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206560-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206560-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206560-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206560-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206560-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206560-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206560-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206560-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206560-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206560-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206560-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206560-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206560-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206560-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206560-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206560-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206560-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206560-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206560-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206560-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206560-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206560-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206560-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206560-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206560-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206560-002AB1782e0a99824c…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
140QMO216EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311681Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c2dbfec8-da5b-cd2b-e053-2a95a90ad17cAvailable on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2409-1metronidazole4 in 1 BOTTLETABLET42
68071-2409-2metronidazole21 in 1 BOTTLETABLET212
68071-2409-3metronidazole30 in 1 BOTTLETABLET302
68071-2409-4metronidazole14 in 1 BOTTLETABLET142
68071-2409-5metronidazole40 in 1 BOTTLETABLET402
68071-2409-7metronidazole20 in 1 BOTTLETABLET202
68071-2409-8metronidazole28 in 1 BOTTLETABLET282
68071-2409-9metronidazole90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2409METRONIDAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 8 package rows20240210_c2dbfec8-da5b-cd2b-e053-2a95a90ad17c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
metronidazoleMETRONIDAZOLEREMEDYREPACK INC.d5784eeb-6b99-4e8a-847b-b0d1090ed48a2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEST. MARY'S MEDICAL PARK PHARMACYe3a32908-9db1-6ca7-e053-2a95a90a82fb2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEREMEDYREPACK INC.b49a8ad0-2cf9-4386-8bf5-1b1df87b00222026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLESportpharm LLCdc8e448e-ac4e-4efc-8851-c368e31b9d692026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.ab695a3e-1721-491a-97a2-c3f617a8d9fc2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLENorthwind Health Company, LLC06bd4afb-4a45-294c-e063-6394a90a7ab12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEPD-Rx Pharmaceuticals, Inc.8f1de4ca-a005-4ca9-a43a-380429c80d6f2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEBryant Ranch Prepack356579f3-a9ed-49cf-bc0d-47b58a58cf852025-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEViona Pharmaceuticals Inc0f108035-d2ab-49c1-9f8d-daae11f0efe02024-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
METRONIDAZOLEMETRONIDAZOLEZydus Lifesciences Limitedf3ef765c-b531-4aaa-a86d-e32b7254ca482024-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEBryant Ranch Prepack9e702861-87f5-4bc0-864d-3170500201942024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEBryant Ranch Prepack1030e723-cde9-44a7-8dab-2f0932ffcc2c2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEAsclemed USA, Inc.89970965-a995-4ae4-a70b-bd2de38081e12024-04-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLENuCare Pharmaceuticals,Inc.c2dbfec8-da5b-cd2b-e053-2a95a90ad17c2024-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
ndc (package): 68071-2409-7
ndc (product): 68071-2409
ndc11 (package): 68071240907

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSNc2dbfec8-da5b-cd2b-e053-2a95a90ad17c2
311681metronidazole 500 MG Oral TabletSCDc2dbfec8-da5b-cd2b-e053-2a95a90ad17c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2409-76807124090720 TABLET in 1 BOTTLE (68071-2409-7) 20 tablet2021-05-210000-00-00NoNoCurrent