Fluconazole
- Product NDC
- 61919-380
- 11-digit product format
- 619190380
- Labeler code
- 61919
- Product ID
- 61919-380_da56d70d-707f-a820-e053-2995a90afc12
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct Rx
- Application
- ANDA076658
- Marketing category
- ANDA
- Marketing start
- 2017-11-01
- Marketing end
- 0000-00-00
- 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
- 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 product | product | 61919-380 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 61919-380 | 61919-380-03 | 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 | 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 | 61919-380-03 | 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 | 61919-380-03 | 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 | 61919-380-03 | 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 | 61919-380-03 | 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 | 61919-380-03 | 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 | 61919-380-03 | 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 | 61919-380-03 | 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 | 61919-380-03 | 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 | 61919-380-03 | 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 | 61919-380-03 | 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 | 61919-380-03 | 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 | 61919-380-03 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076658-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2004-07-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076658-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2004-07-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076658-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2004-07-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076658-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2004-07-29 | caaa826d4ba7… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076658-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076658-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076658-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076658-004 | AB | 1 | caaa826d4ba7… |
| 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… |
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 |
|---|---|---|---|---|---|---|
| 61919-380-03 | Fluconazole | 3 in 1 BOTTLE | TABLET | 3 | 6 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FLUCONAZOLE | ACTIVE INGREDIENT | 8VZV102JFY | DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX] | 1 | |
| FLUCONAZOLE | ACTIVE MOIETY | 8VZV102JFY | DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX] | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX] | 1 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX] | 1 |
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 |
| 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 |
| Fluconazole | FLUCONAZOLE | Direct Rx | 69f199fa-bb92-4837-8b12-427a1c71f622 | 2024-01-09 | Adverse reactions | 61919-380 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197700 | fluconazole 200 MG Oral Tablet | PSN | 69f199fa-bb92-4837-8b12-427a1c71f622 | 6 |
| 197700 | fluconazole 200 MG Oral Tablet | SCD | 69f199fa-bb92-4837-8b12-427a1c71f622 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-380-03 | 61919038003 | 3 TABLET in 1 BOTTLE (61919-380-03) | 3 tablet | 2017-11-01 | 0000-00-00 | No | No | Current |