Fluconazole
- Product NDC
- 43063-326
- 11-digit product format
- 430630326
- Labeler code
- 43063
- Product ID
- 43063-326_dd41ee89-33e6-1081-e053-2995a90ab815
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077253
- Marketing category
- ANDA
- Marketing start
- 2006-01-25
- Marketing end
- 0000-00-00
- Substance
- FLUCONAZOLE
- Active strength
- 100 mg/1
- 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
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 product | product | 43063-326 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 43063-326 | 43063-326-10 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 43063-326 | 43063-326-14 | D | Discontinued by firm | 2026-08-03 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43063-326-14 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43063-326-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43063-326-14 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43063-326-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43063-326-14 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43063-326-10 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43063-326-14 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43063-326-10 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43063-326-14 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43063-326-10 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43063-326-14 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43063-326-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43063-326-14 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43063-326-10 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 43063-326-14 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 43063-326-10 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 43063-326-14 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 43063-326-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 43063-326-14 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 43063-326-10 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 43063-326-14 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 43063-326-10 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 43063-326-14 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 43063-326-10 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077253-001 | FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2006-01-25 | |
| A077253-002 | FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2006-01-25 | |
| A077253-003 | FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2006-01-25 | |
| A077253-004 | FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2006-01-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077253-001 | AB |
| A077253-002 | AB |
| A077253-003 | AB |
| A077253-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077253-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2006-01-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077253-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2006-01-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077253-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2006-01-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077253-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2006-01-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077253-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2006-01-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077253-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2006-01-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077253-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2006-01-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077253-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2006-01-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077253-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2006-01-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077253-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2006-01-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077253-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2006-01-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077253-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2006-01-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077253-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2006-01-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077253-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2006-01-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077253-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2006-01-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077253-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2006-01-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077253-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2006-01-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077253-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2006-01-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077253-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2006-01-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077253-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2006-01-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077253-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2006-01-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077253-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2006-01-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077253-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2006-01-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077253-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2006-01-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077253-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2006-01-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077253-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2006-01-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077253-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2006-01-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077253-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2006-01-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077253-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2006-01-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077253-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2006-01-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077253-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2006-01-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077253-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2006-01-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077253-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2006-01-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077253-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2006-01-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077253-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2006-01-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077253-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2006-01-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077253-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2006-01-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077253-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2006-01-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077253-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2006-01-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077253-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2006-01-25 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077253-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077253-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077253-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077253-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077253-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077253-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077253-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077253-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077253-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077253-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077253-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077253-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077253-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077253-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077253-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077253-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077253-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077253-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077253-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077253-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077253-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077253-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077253-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077253-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077253-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077253-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077253-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077253-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077253-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077253-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077253-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077253-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077253-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077253-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077253-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077253-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077253-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077253-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077253-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077253-004 | AB | 1 | d06236e962d9… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43063-326-10 | EA - Each | 43063-326 | d9d5d553-6d9e-4726-8fb0-c5731eaa2efd | 1 | 2013-05-02 |
| 43063-326-14 | EA - Each | 43063-326 | b3ba23ef-783c-4820-9b7a-4f69daaced97 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FLUCONAZOLE | ACTIVE INGREDIENT | 8VZV102JFY | FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| FLUCONAZOLE | ACTIVE MOIETY | 8VZV102JFY | FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 |
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 | St. Mary's Medical Park Pharmacy | c89c3bbd-1170-4170-e053-2a95a90a8e41 | 2026-07-29 | Warnings, Adverse reactions | 077253 ANDA077253 |
| Fluconazole | FLUCONAZOLE | Northwind Health Company, LLC | 0de7211d-b8ce-214d-e063-6294a90aec41 | 2026-06-22 | Warnings, Adverse reactions | 077253 ANDA077253 |
| Fluconazole | FLUCONAZOLE | PD-Rx Pharmaceuticals, Inc. | dd975843-c3e4-44f4-bb0d-33b294c1f6fb | 2026-06-12 | Warnings, Adverse reactions | 077253 ANDA077253 |
| Fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | e222031d-58f6-46d6-99f8-320b9aacf2b2 | 2026-05-18 | Warnings, Adverse reactions | 077253 ANDA077253 |
| Fluconazole | FLUCONAZOLE | Coupler LLC | 519e44f4-9318-572e-e063-6394a90afe93 | 2026-05-12 | Warnings, Adverse reactions | 077253 ANDA077253 |
| Fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | 2cbf3c6c-318c-4dd9-ad44-a8eb9eccb0f5 | 2026-05-01 | Warnings, Adverse reactions | 077253 ANDA077253 |
| Fluconazole | FLUCONAZOLE | Glenmark Pharmaceuticals Inc., USA | 3da5f41d-5200-45ac-b89d-00881237ec85 | 2026-01-29 | Warnings, Adverse reactions | 077253 ANDA077253 |
| Fluconazole | FLUCONAZOLE | Northwind Health Company, LLC | f76bf2f7-1752-7656-e053-6394a90a8d22 | 2026-01-01 | Warnings, Adverse reactions | 077253 ANDA077253 |
| Fluconazole | FLUCONAZOLE | BluePoint Laboratories | 83bcb8fc-53f1-4d7b-b083-0905b52c6c7e | 2025-12-30 | Warnings, Adverse reactions | 077253 ANDA077253 |
| Fluconazole | FLUCONAZOLE | Radha Pharmaceuticals Inc | 4616c7ad-be61-7ac0-e063-6394a90ab9ed | 2025-12-10 | Warnings, Adverse reactions | 077253 ANDA077253 |
| Fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | aaf9e5f8-048e-407c-bc11-ad4edff85c05 | 2025-08-04 | Warnings, Adverse reactions | 077253 ANDA077253 |
| Fluconazole | FLUCONAZOLE | Coupler LLC | 325d5d69-5132-79ea-e063-6294a90afdd0 | 2025-04-09 | Warnings, Adverse reactions | 077253 ANDA077253 |
| Fluconazole | FLUCONAZOLE | Proficient Rx LP | c0193e27-f1a4-4698-a6bb-3df772c16256 | 2025-04-01 | Warnings, Adverse reactions | 077253 ANDA077253 |
| Fluconazole | FLUCONAZOLE | NuCare Pharmaceuticals,Inc. | cf6c7cca-d074-2178-e053-2a95a90a3af7 | 2025-02-10 | Warnings, Adverse reactions | 077253 ANDA077253 |
| FLUCONAZOLE | FLUCONAZOLE | Direct Rx | db886cfe-ea23-50c9-e053-2995a90a4d10 | 2025-01-22 | Warnings, Adverse reactions | 077253 ANDA077253 |
| Fluconazole | FLUCONAZOLE | A-S Medication Solutions | 2fcac0e4-4f12-42d2-b129-106b4e100075 | 2023-12-03 | Warnings, Adverse reactions | 077253 ANDA077253 |
| Fluconazole | FLUCONAZOLE | Proficient Rx LP | fa2fa2f8-f3a6-4bc0-943c-03dabd0f1581 | 2023-04-01 | Warnings, Adverse reactions | 077253 ANDA077253 |
| Fluconazole | FLUCONAZOLE | Proficient Rx LP | fbb1bda3-f733-4404-9c9d-46c418700c03 | 2022-08-01 | Warnings, Adverse reactions | 077253 ANDA077253 |
| Fluconazole | FLUCONAZOLE | Asclemed USA, Inc. | 56a9de97-bbb9-4210-9ace-f77317d5f33b | 2022-03-04 | Warnings, Adverse reactions | 077253 ANDA077253 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43063-326-10 | 43063032610 | 10 TABLET in 1 BOTTLE, PLASTIC (43063-326-10) | 10 tablet | 2011-05-20 | 0000-00-00 | No | No | Current |
| 43063-326-14 | 43063032614 | 14 TABLET in 1 BOTTLE, PLASTIC (43063-326-14) | 14 tablet | 2011-05-20 | 0000-00-00 | No | No | Current |