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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 41 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 2026-02-19 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077197-001 METRONIDAZOLE 0.75% LOTION / TOPICAL AB 2006-05-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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
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