Home NDC 69784-002 Fluconazole in Sodium Chloride
Product NDC 69784-002
11-digit product format 697840002
Labeler code 69784
Product ID 69784-002_ccff069f-bd5c-41f7-a868-3e86328bb34b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluconazole, Sodium Chloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Woodward Pharma Services LLC
Application ANDA076766
Marketing category ANDA
Marketing start 2020-05-15
Marketing end 0000-00-00
Substance FLUCONAZOLE
Active strength 2 mg/mL
Pharmacologic classes Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
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 1 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69784-002-06 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69784-002-06 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69784-002-06 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69784-002-06 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69784-002-06 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69784-002-06 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69784-002-06 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69784-002-06 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69784-002-06 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69784-002-06 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69784-002-06 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69784-002-06 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 69784-002-06 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 69784-002-06 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 69784-002-06 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 84 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 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076766-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076766-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69784-002 FLUCONAZOLE IN SODIUM CHLORIDE (FLUCONAZOLE, SODIUM CHLORIDE) INJECTION [WOODWARD PHARMA SERVICES LLC] 6 Legacy NDC 20211223_08703ddd-795e-4b69-8d3e-d63bee55d6e9.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69784-002-06 69784000206 6 BAG in 1 CARTON (69784-002-06) > 100 mL in 1 BAG 6 bag 2020-05-15 0000-00-00 No No Current