Fluconazole
- Product NDC
- 55111-146
- 11-digit product format
- 551110146
- Labeler code
- 55111
- Product ID
- 55111-146_69e67aa4-a859-7ab0-79df-d9bf8489998d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Limited
- Application
- ANDA076658
- Marketing category
- ANDA
- Marketing start
- 2014-06-20
- Substance
- FLUCONAZOLE
- Active strength
- 200 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
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076658-001 | FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2004-07-29 | |
| A076658-002 | FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2004-07-29 | |
| A076658-003 | FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2004-07-29 | |
| A076658-004 | FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2004-07-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076658-001 | AB |
| A076658-002 | AB |
| A076658-003 | AB |
| A076658-004 | 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 | A076658-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2004-07-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076658-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2004-07-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076658-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2004-07-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076658-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2004-07-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076658-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2004-07-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076658-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2004-07-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076658-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2004-07-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076658-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2004-07-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076658-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2004-07-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076658-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2004-07-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076658-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2004-07-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076658-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2004-07-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076658-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2004-07-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076658-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2004-07-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076658-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2004-07-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076658-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2004-07-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076658-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2004-07-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076658-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2004-07-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076658-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2004-07-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076658-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2004-07-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076658-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2004-07-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076658-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2004-07-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076658-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2004-07-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076658-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2004-07-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076658-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2004-07-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076658-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2004-07-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076658-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2004-07-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076658-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2004-07-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076658-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2004-07-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076658-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2004-07-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076658-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2004-07-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076658-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2004-07-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076658-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2004-07-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076658-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2004-07-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076658-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2004-07-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076658-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2004-07-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076658-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2004-07-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076658-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2004-07-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076658-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2004-07-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076658-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2004-07-29 | 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 | A076658-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076658-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076658-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076658-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076658-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076658-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076658-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076658-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076658-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076658-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076658-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076658-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076658-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076658-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076658-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076658-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076658-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076658-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076658-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076658-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076658-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076658-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076658-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076658-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076658-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076658-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076658-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076658-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076658-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076658-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076658-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076658-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076658-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076658-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076658-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076658-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076658-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076658-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076658-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076658-004 | AB | 1 | d06236e962d9… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluconazole
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FLUCONAZOLE | 200 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8VZV102JFY | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d7fa1d79-4cd3-4a55-b74b-b31e82e616a3 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 74f0b828-cb79-42cb-bb6c-81c9f5bd2648 | Product name | 2 | 20250623 |
| fe6bb120-ebc6-6290-9eab-e842fdb6c841 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55111-146-01 | Fluconazole | 100 in 1 BOTTLE | TABLET | 100 | 19 | |
| 55111-146-05 | Fluconazole | 500 in 1 BOTTLE | TABLET | 500 | 19 | |
| 55111-146-30 | Fluconazole | 30 in 1 BOTTLE | TABLET | 30 | 19 | |
| 55111-146-78 | Fluconazole | 10 in 1 CARTON | TABLET | 10 | 19 | |
| 55111-146-79 | Fluconazole | 10 in 1 DOSE PACK | TABLET | 10 | 19 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55111-146-01 | EA - Each | 55111-146 | d9737376-8d37-4a4e-8bce-8c847fb083dc | 1 | 2015-01-05 |
| 55111-146-30 | EA - Each | 55111-146 | 3ae3001c-2e73-43f9-acd5-45b2962394e5 | 1 | 2015-01-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | Cardinal Health 107, LLC | f1bfba3a-5b18-41c0-9084-b1f26bb93ef2 | 2026-04-27 | Warnings, Adverse reactions | 076658 ANDA076658 |
| Fluconazole | FLUCONAZOLE | Sportpharm LLC | 8a4d6d9e-02ae-42e4-83ec-f5c4e135273b | 2026-04-24 | Warnings, Adverse reactions | 076658 ANDA076658 |
| Fluconazole | FLUCONAZOLE | Major Pharmaceuticals | 13184b13-e252-4b4d-a3e2-cfc4ad3d55b7 | 2026-03-19 | Warnings, Adverse reactions | 076658 ANDA076658 |
| Fluconazole | FLUCONAZOLE | Dr. Reddy's Laboratories Limited | d7fa1d79-4cd3-4a55-b74b-b31e82e616a3 | 2025-09-23 | Warnings, Adverse reactions | 076658 ANDA076658 55111-146 |
| FLUCONAZOLE | FLUCONAZOLE | direct rx | b3db505a-9677-6f5a-e053-2a95a90a13d4 | 2025-01-17 | Warnings, Adverse reactions | 076658 ANDA076658 |
| Fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | a499c43e-0454-4a8c-a547-31e9816babdd | 2024-10-07 | Warnings, Adverse reactions | 076658 ANDA076658 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55111-146-01 | 55111014601 | 100 TABLET in 1 BOTTLE (55111-146-01) | 100 tablet | 2014-06-20 | 0000-00-00 | No | No | Current |
| 55111-146-05 | 55111014605 | 500 TABLET in 1 BOTTLE (55111-146-05) | 500 tablet | 2014-06-20 | 0000-00-00 | No | No | Current |
| 55111-146-30 | 55111014630 | 30 TABLET in 1 BOTTLE (55111-146-30) | 30 tablet | 2014-06-20 | 0000-00-00 | No | No | Current |
| 55111-146-78 | 55111014678 | 10 DOSE PACK in 1 CARTON (55111-146-78) / 10 TABLET in 1 DOSE PACK (55111-146-79) | 10 dose pack | 2014-06-20 | 0000-00-00 | No | No | Current |
| 55111-146-79 | 55111014679 | 10 in 1 DOSE PACK | Historical |