Home NDC 50111-333 Metronidazole
Product NDC 50111-333
11-digit product format 501110333
Labeler code 50111
Product ID 50111-333_c6f82723-a668-4dc1-96ea-816620a5b964
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA070027
Marketing category ANDA
Marketing start 1990-09-30
Substance METRONIDAZOLE
Active strength 250 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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070027-001 METRONIDAZOLE METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070027-001 AB
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 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070027-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-11-06 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Metronidazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METRONIDAZOLE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 140QMO216E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311681 Internal RxNorm lookup 314106 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50111-333-01 Metronidazole 100 in 1 BOTTLE TABLET 100 18 50111-333-02 Metronidazole 500 in 1 BOTTLE TABLET 500 18 50111-333-06 Metronidazole 250 in 1 BOTTLE TABLET 250 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE TABLET [PLIVA INC.] 5 METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE TABLET [READYMEDS] 5 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE TABLET [PLIVA INC.] 5 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE TABLET [READYMEDS] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METRONIDAZOLE TABLET [READYMEDS] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METRONIDAZOLE TABLET [PLIVA INC.] 5 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK METRONIDAZOLE TABLET [READYMEDS] 5 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK METRONIDAZOLE TABLET [PLIVA INC.] 5 HYDROGENATED COTTONSEED OIL INACTIVE INGREDIENT Z82Y2C65EA METRONIDAZOLE TABLET [PLIVA INC.] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METRONIDAZOLE TABLET [READYMEDS] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METRONIDAZOLE TABLET [PLIVA INC.] 5 METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP] 4 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP] 4 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK METRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP] 4 HYDROGENATED COTTONSEED OIL INACTIVE INGREDIENT Z82Y2C65EA METRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP] 4 METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE (METRONIDAZOLE) TABLET [STAT RX USA LLC] 2 METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE TABLET [CARILION MATERIALS MANAGEMENT] 2 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE (METRONIDAZOLE) TABLET [STAT RX USA LLC] 2 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE TABLET [CARILION MATERIALS MANAGEMENT] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METRONIDAZOLE (METRONIDAZOLE) TABLET [STAT RX USA LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METRONIDAZOLE TABLET [CARILION MATERIALS MANAGEMENT] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK METRONIDAZOLE (METRONIDAZOLE) TABLET [STAT RX USA LLC] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK METRONIDAZOLE TABLET [CARILION MATERIALS MANAGEMENT] 2 HYDROGENATED COTTONSEED OIL INACTIVE INGREDIENT Z82Y2C65EA METRONIDAZOLE (METRONIDAZOLE) TABLET [STAT RX USA LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METRONIDAZOLE TABLET [CARILION MATERIALS MANAGEMENT] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METRONIDAZOLE (METRONIDAZOLE) TABLET [STAT RX USA LLC] 2 METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.] 1 METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.] 1 METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE TABLET [PROFICIENT RX LP] 1 METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE TABLET [MAJOR PHARMACEUTICALS] 1 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.] 1 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE TABLET [PROFICIENT RX LP] 1 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE TABLET [MAJOR PHARMACEUTICALS] 1 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METRONIDAZOLE TABLET [PROFICIENT RX LP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METRONIDAZOLE TABLET [MAJOR PHARMACEUTICALS] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK METRONIDAZOLE TABLET [MAJOR PHARMACEUTICALS] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK METRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK METRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK METRONIDAZOLE TABLET [PROFICIENT RX LP] 1 HYDROGENATED COTTONSEED OIL INACTIVE INGREDIENT Z82Y2C65EA METRONIDAZOLE TABLET [H.J. HARKINS COMPANY, INC.] 1 HYDROGENATED COTTONSEED OIL INACTIVE INGREDIENT Z82Y2C65EA METRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.] 1 HYDROGENATED COTTONSEED OIL INACTIVE INGREDIENT Z82Y2C65EA METRONIDAZOLE TABLET [MAJOR PHARMACEUTICALS] 1 HYDROGENATED COTTONSEED OIL INACTIVE INGREDIENT Z82Y2C65EA METRONIDAZOLE TABLET [PROFICIENT RX LP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METRONIDAZOLE TABLET [LIBERTY PHARMACEUTICALS, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METRONIDAZOLE TABLET [MAJOR PHARMACEUTICALS] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METRONIDAZOLE TABLET [PROFICIENT RX LP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50111-333 METRONIDAZOLE TABLET [TEVA PHARMACEUTICALS USA, INC.] 18 Current NDC, Legacy NDC, 3 package rows 20240724_291a45f6-ed27-4dcc-8364-358d08623797.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Metronidazole METRONIDAZOLE REMEDYREPACK INC. ca450fad-0513-4c45-8ea0-1f46bcbf6a36 2026-03-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070027 application number: ANDA070027 Metronidazole METRONIDAZOLE Bryant Ranch Prepack ea635d05-b3c1-4f49-ace2-d091c20920da 2024-08-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070027 application number: ANDA070027 Metronidazole METRONIDAZOLE Teva Pharmaceuticals USA, Inc. 291a45f6-ed27-4dcc-8364-358d08623797 2024-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070027 application number: ANDA070027 ndc (product): 50111-333 Metronidazole METRONIDAZOLE Proficient Rx LP 205054e1-8172-47dc-931c-a18a60e7e9f0 2022-12-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070027 application number: ANDA070027
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50111-333-01 50111033301 100 TABLET in 1 BOTTLE (50111-333-01) 100 tablet 1990-09-30 0000-00-00 No No Current 50111-333-02 50111033302 500 TABLET in 1 BOTTLE (50111-333-02) 500 tablet 1990-09-30 0000-00-00 No No Current 50111-333-06 50111033306 250 TABLET in 1 BOTTLE (50111-333-06) 250 tablet 1990-09-30 0000-00-00 No No Current