Fluconazole
- Product NDC
- 55700-521
- Requested package NDC
- 55700-521-01
- 11-digit product format
- 557000521
- Labeler code
- 55700
- Product ID
- 55700-521_3b5e21d1-25be-4a3b-9829-8cc112ddd36f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA078423
- Marketing category
- ANDA
- Marketing start
- 2017-02-24
- Marketing end
- 0000-00-00
- Substance
- FLUCONAZOLE
- Active strength
- 150 mg/1
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 55700-521 | 55700-521-01 | D | Discontinued by firm | 2026-08-17 |
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.
| Captured / source date | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078423-001 | FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | |
| A078423-002 | FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | |
| A078423-003 | FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | |
| A078423-004 | FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078423-001 | AB |
| A078423-002 | AB |
| A078423-003 | AB |
| A078423-004 | 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.
| 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 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078423-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078423-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078423-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078423-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078423-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078423-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078423-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078423-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078423-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078423-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078423-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078423-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078423-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078423-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078423-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078423-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078423-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078423-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078423-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078423-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078423-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078423-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078423-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078423-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078423-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078423-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078423-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078423-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078423-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078423-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078423-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078423-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078423-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078423-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078423-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078423-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078423-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078423-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078423-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078423-004 | AB | 1 | d8e5a09893c0… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55700-521-01 | 2025-01-09 | C162847 | 48780-1 | f386c649-dd7d-0266-e053-dadaa90a7c1a | Fluconazole Tablets, USP |
| 55700-521-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-dd7d-0266-e053-dadaa90a7c1a | Fluconazole Tablets, USP |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-521-01 | EA - Each | 55700-521 | a2f79348-b512-442f-9a9d-9ce5f395a6b3 | 1 | 2017-06-15 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | 91adb548-9875-47e9-8054-578ed8c7572e | 2026-06-10 | Warnings, Adverse reactions | 078423 ANDA078423 |
| Fluconazole | FLUCONAZOLE | Golden State Medical Supply, Inc. | c2c7242d-d172-4733-e053-2995a90acb2e | 2026-02-10 | Warnings, Adverse reactions | 078423 ANDA078423 |
| Fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 2c9abaee-461f-437d-adda-e96d7ae3dd01 | 2026-01-23 | Warnings, Adverse reactions | 078423 ANDA078423 |
| Fluconazole | FLUCONAZOLE | A-S Medication Solutions | a0f1c111-e11e-4b7e-b990-8bc271cbc940 | 2026-01-14 | Warnings, Adverse reactions | 078423 ANDA078423 |
| Fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 701cd91f-4f79-48a7-8fe5-a9678d7a4ac8 | 2025-10-06 | Warnings, Adverse reactions | 078423 ANDA078423 |
| Fluconazole | FLUCONAZOLE | ANI Pharmaceuticals, Inc. | 8f90f169-6a72-4c33-a2af-0bc943602bc2 | 2025-08-08 | Warnings, Adverse reactions | 078423 ANDA078423 |
| Fluconazole | FLUCONAZOLE | PD-Rx Pharmaceuticals, Inc. | d9e772e9-d916-42ae-8020-89b263236102 | 2025-04-17 | Warnings, Adverse reactions | 078423 ANDA078423 |
| Fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | c94b8ecf-249f-42d6-a030-4cfb83fddb08 | 2024-10-08 | Warnings, Adverse reactions | 078423 ANDA078423 |
| Fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 877aea10-b019-4eeb-8a1e-e6ac583df966 | 2024-10-08 | Warnings, Adverse reactions | 078423 ANDA078423 |
| Fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | b94ca865-ab2f-466c-9913-dde9376e4533 | 2024-10-08 | Warnings, Adverse reactions | 078423 ANDA078423 |
| Fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 6b2bc10f-21a8-422a-9ea3-ed7788ffce6b | 2024-10-07 | Warnings, Adverse reactions | 078423 ANDA078423 |
| Fluconazole | FLUCONAZOLE | Proficient Rx LP | b0aa9b22-5aef-459f-bb11-b193343eeb86 | 2023-02-01 | Warnings, Adverse reactions | 078423 ANDA078423 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55700-521-01 | 55700052101 | 1 TABLET in 1 BLISTER PACK (55700-521-01) | 1 tablet | 2017-05-05 | 0000-00-00 | No | No | Current |