Home NDC 0409-4688 Fluconazole in Sodium Chloride
Product NDC 0409-4688
11-digit product format 004094688
Labeler code 0409
Product ID 0409-4688_7d067fc8-7c07-4eb2-ab3e-2f99c6015875
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluconazole in Sodium Chloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA076303
Marketing category ANDA
Marketing start 2006-04-17
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 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A076303-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 A076303-002 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 · 86 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 2026-09-14 22:38:34 2026-08 A076303-001 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076303-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076303-001 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 A076303-002 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 A076303-001 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 A076303-002 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 A076303-001 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 A076303-002 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 A076303-001 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 A076303-002 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 A076303-001 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 A076303-002 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 A076303-001 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 A076303-002 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 A076303-001 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 A076303-002 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 A076303-001 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 A076303-002 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 A076303-001 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 A076303-002 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 A076303-001 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 A076303-002 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 A076303-001 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 A076303-002 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 A076303-001 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 A076303-002 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 A076303-001 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 A076303-002 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 A076303-001 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 A076303-002 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 A076303-001 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 A076303-002 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 A076303-001 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 A076303-002 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 A076303-001 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 A076303-002 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 A076303-001 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 A076303-002 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 A076303-001 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 A076303-002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 400MG/200ML (2MG/ML) INJECTABLE / INJECTION AP 2004-07-29 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUCONAZOLE ACTIVE INGREDIENT 8VZV102JFY FLUCONAZOLE INJECTION, SOLUTION [HOSPIRA, INC.] 12 FLUCONAZOLE ACTIVE MOIETY 8VZV102JFY FLUCONAZOLE INJECTION, SOLUTION [HOSPIRA, INC.] 12 DEXTROSE MONOHYDRATE INACTIVE INGREDIENT LX22YL083G FLUCONAZOLE INJECTION, SOLUTION [HOSPIRA, INC.] 12 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X FLUCONAZOLE INJECTION, SOLUTION [HOSPIRA, INC.] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-4688 FLUCONAZOLE IN SODIUM CHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 29 Legacy NDC 20240627_b3efaffa-9ef9-4a4f-998e-aa7d2eb61fc9.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0409-4688-12 00409468812 24 BAG in 1 CASE (0409-4688-12) > 200 mL in 1 BAG (0409-4688-16) 24 bag 2015-10-21 0000-00-00 No No Current 0409-4688-18 00409468818 24 BAG in 1 CASE (0409-4688-18) > 100 mL in 1 BAG (0409-4688-22) 24 bag 2015-12-18 0000-00-00 No No Current