Fluconazole
- Product NDC
- 53002-2198
- Requested package NDC
- 53002-2198-2
- 11-digit product format
- 530022198
- Labeler code
- 53002
- Product ID
- 53002-2198_48f18832-27ad-48cd-8220-bbaa2a4bd72c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA077731
- Marketing category
- ANDA
- Marketing start
- 2008-10-07
- 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
- 2021-12-31
- 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 | 53002-2198 | 53002-2198-2 | I | Inactivated by FDA | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | 9bebd1f3094a… | 5416666fcb17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077731-001 | FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | |
| A077731-002 | FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | |
| A077731-003 | FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | |
| A077731-004 | FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077731-001 | AB |
| A077731-002 | AB |
| A077731-003 | AB |
| A077731-004 | 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 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | 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 | A077731-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077731-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077731-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077731-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077731-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077731-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077731-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077731-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077731-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077731-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077731-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077731-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077731-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077731-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077731-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077731-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077731-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077731-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077731-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077731-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077731-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077731-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077731-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077731-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077731-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077731-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077731-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077731-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077731-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077731-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077731-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077731-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077731-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077731-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077731-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077731-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077731-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077731-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077731-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077731-004 | AB | 1 | d06236e962d9… |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 53002-2198-1 | 2023-01-30 | Fluconazole Tablets USP Rx only |
| 53002-2198-2 | 2023-01-30 | Fluconazole Tablets USP Rx only |
| 53002-2198-1 | 2020-12-15 | Fluconazole Tablets USP Rx only |
| 53002-2198-2 | 2020-12-15 | Fluconazole Tablets USP Rx only |
| 53002-2198-1 | 2020-01-31 | Fluconazole Tablets USP Rx only |
| 53002-2198-2 | 2020-01-31 | Fluconazole Tablets USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-2198-1 | Fluconazole | 12 in 1 CARTON | TABLET | 12 | 3 | |
| 53002-2198-1 | Fluconazole | 1 in 1 BLISTER PACK | TABLET | 1 | 3 | |
| 53002-2198-2 | Fluconazole | 1 in 1 BLISTER PACK | TABLET | 1 | 3 | |
| 53002-2198-2 | Fluconazole | 12 in 1 CARTON | TABLET | 12 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-2198 | FLUCONAZOLE TABLET [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 4 package rows | 20201217_fbcb4da9-e8ba-40d3-a596-dc60cde80fa6.zip |
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 | Redpharm Drug | 568d9f2f-3394-b972-e063-6394a90a8628 | 2026-07-14 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | PD-Rx Pharmaceuticals, Inc. | 6bb386b0-9dbe-40ee-b873-5215b1905920 | 2026-07-14 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | St. Mary's Medical Park Pharmacy | 126406ae-1fdc-df20-e063-6294a90a2718 | 2026-06-29 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | A-S Medication Solutions | a995790a-8470-4c51-801a-69347151a6fe | 2026-06-24 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | 726daf35-4c03-464f-a814-cc0a715d6031 | 2026-06-12 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | ASCLEMED USA INC. | 2099c3a0-1911-4d4a-878a-36cf054bdd0b | 2026-05-20 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | Preferred Pharmaceuticals Inc. | eeeb82e1-d668-418e-9716-f8bcf72f80c0 | 2026-04-17 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | Preferred Pharmaceuticals Inc. | 5cbd78cd-2cd7-4882-9902-bdb7812fbc6b | 2026-04-16 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | A-S Medication Solutions | f25f31a6-4bad-40fa-bced-695552e27afd | 2026-02-17 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | Sportpharm LLC | 60f3e8af-d98f-48dd-83e6-a78315aaed22 | 2026-02-15 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | Sportpharm LLC | 98ac5455-d26c-4780-a5a3-bf8d85917626 | 2026-02-09 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | AvPAK | 551a5c8f-57eb-2643-12c6-7c700584b49f | 2026-01-06 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | Northwind Health Company, LLC | c924c51c-ed7e-7e72-e053-2995a90adcd3 | 2026-01-01 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | NuCare Pharmaceuticals,Inc. | 124c1ffa-08fd-eca5-e063-6294a90af0e2 | 2025-12-17 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | A-S Medication Solutions | c6be26bb-af92-405b-9908-972d6e985cf0 | 2025-12-01 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | NuCare Pharmaceuticals,Inc. | 01df20c4-7b94-044e-e063-6394a90a406a | 2025-11-17 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | PD-Rx Pharmaceuticals, Inc. | 28d53f27-a0cd-4d8d-e054-00144ff8d46c | 2025-10-15 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | 1c82929f-934b-4df4-b24f-1e5da090fd8a | 2025-10-02 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | 2bd1c038-ab82-496c-8129-3182238ad1a1 | 2025-09-30 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | Proficient Rx LP | fef2222c-5d61-435e-8761-d8f3d435d6d8 | 2025-09-01 | Warnings, Adverse reactions | 077731 ANDA077731 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197699 | fluconazole 150 MG Oral Tablet | PSN | fbcb4da9-e8ba-40d3-a596-dc60cde80fa6 | 3 |
| 197699 | fluconazole 150 MG Oral Tablet | SCD | fbcb4da9-e8ba-40d3-a596-dc60cde80fa6 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-2198-2 | 53002219802 | 12 BLISTER PACK in 1 CARTON (53002-2198-2) > 1 TABLET in 1 BLISTER PACK | 12 blister pack | 2018-10-01 | 0000-00-00 | No | No | Current |