Home NDC 0168-0383 Metronidazole
Product NDC 0168-0383
11-digit product format 001680383
Labeler code 0168
Product ID 0168-0383_76e5eaff-57c7-4120-af16-c7e8cbac8688
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form LOTION
Route TOPICAL
Labeler Fougera Pharmaceuticals, LLC
Application ANDA077197
Marketing category ANDA
Marketing start 2006-05-24
Substance METRONIDAZOLE
Active strength 7.5 mg/mL
Pharmacologic classes Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0168-0383-60 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0168-0383-60 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 0168-0383-60 8dfbde2a14a4…c9ff85d89658…
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 A077197-001 METRONIDAZOLE METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077197-001 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 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METRONIDAZOLE 7.5 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 242736 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 0168-0383-60 Metronidazole 59 mL in 1 BOTTLE, PLASTIC LOTION 59 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT F68VH75CJC METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 LIGHT MINERAL OIL INACTIVE INGREDIENT N6K5787QVP METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 STEARETH-21 INACTIVE INGREDIENT 53J3F32P58 METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] 2 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] 2 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] 2 CYCLOMETHICONE 5 INACTIVE INGREDIENT 0THT5PCI0R METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] 2 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] 2 LIGHT MINERAL OIL INACTIVE INGREDIENT N6K5787QVP METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] 2 POLYOXYL 100 STEARATE INACTIVE INGREDIENT YD01N1999R METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] 2 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] 2 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0168-0383 METRONIDAZOLE LOTION [FOUGERA PHARMACEUTICALS INC.] 8 Current NDC, Legacy NDC, 1 package rows 20220708_5368755a-dd37-4e34-843f-ece6bac8ef6a.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 · 1 matching rows.
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 0168-0383-60 00168038360 59 mL in 1 BOTTLE, PLASTIC (0168-0383-60) 59 ml 2006-05-24 0000-00-00 No No Current