Fluconazole
- Product NDC
- 0143-9669
- 11-digit product format
- 001439669
- Labeler code
- 0143
- Product ID
- 0143-9669_a90257a3-d842-4990-81a5-614293e23119
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA078698
- Marketing category
- ANDA
- Marketing start
- 2012-01-30
- Substance
- FLUCONAZOLE
- Active strength
- 2 mg/mL
- 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 |
|---|---|---|---|---|---|---|---|
| A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | |
| A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078698-001 | AP |
| A078698-002 | AP |
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 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078698-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078698-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | 2012-01-30 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078698-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078698-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078698-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078698-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078698-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078698-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078698-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078698-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078698-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078698-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078698-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078698-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078698-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078698-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078698-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078698-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078698-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078698-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078698-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078698-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078698-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078698-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078698-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078698-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078698-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078698-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078698-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078698-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078698-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A078698-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078698-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078698-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078698-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078698-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078698-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078698-002 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078698-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078698-002 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078698-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078698-002 | AP | 1 | bb7c543d1eb4… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluconazole
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FLUCONAZOLE | 2 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8VZV102JFY | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d3ca59bd-ae00-48ab-89aa-87c7f56e9989 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 74f0b828-cb79-42cb-bb6c-81c9f5bd2648 | Product name | 2 | 20250623 |
| cb89b86a-369e-4204-8910-ae797c503af3 | Product name | 1 | 20230706 |
| d4880ace-a516-8c47-8dfd-73a4ba5887d7 | Product name | 2 | 20180830 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| fe6bb120-ebc6-6290-9eab-e842fdb6c841 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0143-9669-01 | Fluconazole | 100 mL in 1 CONTAINER | INJECTION | 100 | 19 | |
| 0143-9669-10 | Fluconazole | 10 in 1 CARTON | INJECTION | 10 | 19 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0143-9669-01 | ML - Milliliter | 0143-9669 | e4e52a96-6d31-4a00-ae48-41d86f18f423 | 1 | 2013-05-02 |
| 0143-9669-06 | ML - Milliliter | 0143-9669 | 652f456f-16c2-4a8d-8083-85769d251289 | 1 | 2013-05-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FLUCONAZOLE | ACTIVE INGREDIENT | 8VZV102JFY | FLUCONAZOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP] | 9 | |
| FLUCONAZOLE | ACTIVE MOIETY | 8VZV102JFY | FLUCONAZOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP] | 9 | |
| DEXTROSE MONOHYDRATE | INACTIVE INGREDIENT | LX22YL083G | FLUCONAZOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP] | 9 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | FLUCONAZOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP] | 9 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | FLUCONAZOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP] | 9 |
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 | Hikma Pharmaceuticals USA Inc. | d3ca59bd-ae00-48ab-89aa-87c7f56e9989 | 2024-06-28 | Warnings, Adverse reactions | 078698 ANDA078698 0143-9669 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1721315 | fluconazole 200 MG in 100 ML Injection | PSN | d3ca59bd-ae00-48ab-89aa-87c7f56e9989 | 19 |
| 1721314 | fluconazole 400 MG in 200 ML Injection | PSN | d3ca59bd-ae00-48ab-89aa-87c7f56e9989 | 19 |
| 1721315 | 100 ML fluconazole 2 MG/ML Injection | SCD | d3ca59bd-ae00-48ab-89aa-87c7f56e9989 | 19 |
| 1721314 | 200 ML fluconazole 2 MG/ML Injection | SCD | d3ca59bd-ae00-48ab-89aa-87c7f56e9989 | 19 |
| 1721315 | fluconazole 200 MG per 100 ML Injection | SY | d3ca59bd-ae00-48ab-89aa-87c7f56e9989 | 19 |
| 1721314 | fluconazole 400 MG per 200 ML Injection | SY | d3ca59bd-ae00-48ab-89aa-87c7f56e9989 | 19 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0143-9669-01 | 00143966901 | 100 mL in 1 CONTAINER | 100 ml | Historical | ||||
| 0143-9669-06 | 00143966906 | 6 CONTAINER in 1 CARTON (0143-9669-06) > 100 mL in 1 CONTAINER (0143-9669-01) | 6 container | 2012-01-30 | 0000-00-00 | No | No | Current |
| 0143-9669-10 | 00143966910 | 10 CONTAINER in 1 CARTON (0143-9669-10) / 100 mL in 1 CONTAINER (0143-9669-01) | 10 container | 2012-01-30 | No | No | Current |