fluconazole
- Product NDC
- 60760-113
- 11-digit product format
- 607600113
- Labeler code
- 60760
- Product ID
- 60760-113_7a8db339-b98e-6fab-e053-2a91aa0a1247
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- St. Mary's Medical Park Pharmacy
- Application
- ANDA208963
- Marketing category
- ANDA
- Marketing start
- 2018-03-14
- 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
- 2020-12-31
- 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 | 60760-113 | D | Discontinued by firm | 2026-08-07 | ||
| excluded package | package | 60760-113 | 60760-113-01 | D | Discontinued by firm | 2026-08-07 |
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 | 60760-113-01 | 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 | 60760-113-01 | 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 | 60760-113-01 | 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 | 60760-113-01 | 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 | 60760-113-01 | 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 | 60760-113-01 | 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 | 60760-113-01 | 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 | 60760-113-01 | 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 | 60760-113-01 | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208963-001 | FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | |
| A208963-002 | FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | |
| A208963-003 | FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | |
| A208963-004 | FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208963-001 | AB |
| A208963-002 | AB |
| A208963-003 | AB |
| A208963-004 | 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 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | 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 | A208963-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208963-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208963-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208963-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208963-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208963-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208963-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208963-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208963-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208963-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208963-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208963-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208963-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208963-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208963-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208963-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208963-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208963-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208963-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208963-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208963-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208963-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208963-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208963-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208963-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208963-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208963-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208963-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208963-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208963-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208963-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208963-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208963-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208963-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208963-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208963-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A208963-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208963-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208963-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208963-004 | AB | 1 | d06236e962d9… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60760-113-01 | EA - Each | 60760-113 | 068be9d0-b95b-4bbc-aa48-f037ed944dd6 | 1 | 2018-06-11 |
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 | A-S Medication Solutions | 7961c029-746c-48c3-888b-8f8344102873 | 2026-07-30 | Warnings, Adverse reactions | 208963 ANDA208963 |
| fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | b5cfe0a1-f55c-41b1-8ad6-d1d0134a4d1d | 2026-07-23 | Warnings, Adverse reactions | 208963 ANDA208963 |
| fluconazole | FLUCONAZOLE | Preferred Pharmaceuticals Inc. | 16b6fba0-b96f-4252-a70d-31dc61400298 | 2026-07-22 | Warnings, Adverse reactions | 208963 ANDA208963 |
| fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 67af604c-928f-468b-ba27-ad45e95d3e7e | 2026-06-24 | Warnings, Adverse reactions | 208963 ANDA208963 |
| fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 7259671f-a703-4a2a-81db-9a4839b34072 | 2026-06-24 | Warnings, Adverse reactions | 208963 ANDA208963 |
| fluconazole | FLUCONAZOLE | Zydus Pharmaceuticals (USA) Inc. | d1364455-1537-46d4-b093-38cca3be778f | 2026-04-07 | Warnings, Adverse reactions | 208963 ANDA208963 |
| fluconazole | FLUCONAZOLE | A-S Medication Solutions | 1a8bd42a-2bce-4b41-8678-67033e7707dd | 2026-01-13 | Warnings, Adverse reactions | 208963 ANDA208963 |
| FLUCONAZOLE | FLUCONAZOLE | direct rx | b3db505a-9677-6f5a-e053-2a95a90a13d4 | 2025-01-17 | Warnings, Adverse reactions | 208963 ANDA208963 |
| fluconazole | FLUCONAZOLE | NuCare Pharmaceuticals,Inc. | 715c53f0-2aea-1f24-e053-2995a90ad463 | 2024-06-10 | Warnings, Adverse reactions | 208963 ANDA208963 |
| fluconazole | FLUCONAZOLE | Zydus Lifesciences Limited | 0adb2f88-8a6f-4f33-9e2d-73f537e05313 | 2024-03-04 | Warnings, Adverse reactions | 208963 ANDA208963 |
| Fluconazole | FLUCONAZOLE | Direct Rx | 69f199fa-bb92-4837-8b12-427a1c71f622 | 2024-01-09 | Adverse reactions | 208963 ANDA208963 |
| fluconazole | FLUCONAZOLE | A-S Medication Solutions | 08a54805-4fdf-48fd-bc3e-e9fa38f3c691 | 2023-02-06 | Warnings, Adverse reactions | 208963 ANDA208963 |
| fluconazole | FLUCONAZOLE | Proficient Rx LP | f232600e-70ce-4001-b9da-31442f0920b9 | 2020-03-01 | Warnings, Adverse reactions | 208963 ANDA208963 |
| fluconazole | FLUCONAZOLE | Proficient Rx LP | 7c8bb5ff-37e7-4f5e-8ea7-12269b2c7fd3 | 2019-10-01 | Warnings, Adverse reactions | 208963 ANDA208963 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 60760-113-01 | 60760011301 | 1 BLISTER PACK in 1 CARTON (60760-113-01) > 1 TABLET in 1 BLISTER PACK | 1 blister pack | 2018-03-14 | 0000-00-00 | No | No | Current |