Home NDC 10544-938 Metronidazole
Product NDC 10544-938
11-digit product format 105440938
Labeler code 10544
Product ID 10544-938_1bf3b606-e931-5233-e054-00144ff88e88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form TABLET
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA070044
Marketing category ANDA
Marketing start 2015-07-27
Marketing end 0000-00-00
Substance METRONIDAZOLE
Active strength 500 mg/1
Pharmacologic classes Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A070044-001 METRONIDAZOLE METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070044-001 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 · 44 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 2026-10-15 13:18:30 2026-09 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 c2088c7a36db…2026-09-14 22:38:34 2026-08 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070044-001 METRONIDAZOLE 500MG TABLET / ORAL AB 1985-02-08 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 A070044-001 AB 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070044-001 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A070044-001 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A070044-001 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10544-938-14 Metronidazole 14 in 1 BOTTLE, PLASTIC TABLET 14 3 10544-938-30 Metronidazole 30 in 1 BOTTLE TABLET 30 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] 3 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] 3 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-938 METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] 3 Legacy NDC, 2 package rows 20150728_1bdfb0e3-8397-6a61-e054-00144ff88e88.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10544-938-14 10544093814 14 in 1 BOTTLE, PLASTIC Historical 10544-938-30 10544093830 30 in 1 BOTTLE Historical