Vagistat-3
- Product NDC
- 0067-2091
- 11-digit product format
- 000672091
- Labeler code
- 0067
- Product ID
- 0067-2091_c91cba6b-61fc-4708-9edb-3ba086cc1038
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole nitrate
- Dosage form
- KIT
- Labeler
- Novartis Consumer Health, Inc.
- Application
- ANDA075329
- Marketing category
- ANDA
- Marketing start
- 2000-02-25
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 | 0067-2091 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 0067-2091 | 0067-2091-03 | 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 | 0067-2091-03 | 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 | 0067-2091-03 | 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 | 0067-2091-03 | 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 | 0067-2091-03 | 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 | 0067-2091-03 | 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 | 0067-2091-03 | 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 | 0067-2091-03 | 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 | 0067-2091-03 | 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 | 0067-2091-03 | 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 | 0067-2091-03 | 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 | 0067-2091-03 | 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 | 0067-2091-03 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | MICONAZOLE NITRATE | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 |
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 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A075329-001 | MICONAZOLE NITRATE COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-20 | e64feba35796… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 3a55f4fb-5aec-4c88-0ff7-4d608ad4866a | Product name | 1 | 20140508 |
| 5b9a7965-36d2-8412-dcaf-f76a65411611 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0067-2091-03 | EA - Each | 0067-2091 | 85e38eb1-76b1-4f4b-b4a0-0d1f784e2da4 | 1 | 2014-10-03 |
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 992792 | {1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Vagistat]) / 3 (miconazole nitrate 200 MG Vaginal Insert [Vagistat]) } Pack [Vagistat 3 Day Combination Pack] | BPCK | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 992766 | {1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } Pack | GPCK | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 998540 | miconazole nitrate 2 % Vaginal Cream | PSN | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 992765 | miconazole nitrate 200 MG Vaginal Insert | PSN | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 992766 | miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) Pack | PSN | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 1359442 | Vagistat 2 % Vaginal Cream | PSN | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 992792 | Vagistat 3 Combination Pack | PSN | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 992791 | Vagistat-3 200 MG Vaginal Insert | PSN | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 1359442 | miconazole nitrate 20 MG/ML Vaginal Cream [Vagistat] | SBD | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 992791 | miconazole nitrate 200 MG Vaginal Insert [Vagistat] | SBD | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 998540 | miconazole nitrate 20 MG/ML Vaginal Cream | SCD | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 992765 | miconazole nitrate 200 MG Vaginal Insert | SCD | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 992766 | miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream) | SY | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 992766 | miconazole 3 Day Vaginal Insert Combination Pack | SY | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 998540 | miconazole nitrate 2 % Vaginal Cream | SY | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 1359442 | Vagistat 2 % Vaginal Cream | SY | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 992791 | Vagistat 200 MG Vaginal Insert | SY | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 992792 | Vagistat 3 Combination Pack | SY | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 1359442 | Vagistat-3 2 % Vaginal Cream | SY | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |
| 992791 | Vagistat-3 200 MG Vaginal Insert | SY | b5998ee2-d22b-4f3f-adf6-99482b1f7946 | 3 |