Miconazole 7
- Product NDC
- 49781-064
- 11-digit product format
- 497810064
- Labeler code
- 49781
- Product ID
- 49781-064_caa1c3b2-633c-44c2-8c6c-363e6df16912
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole Nitrate
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Cardinal Health (Leader) 49781
- Application
- ANDA074164
- Marketing category
- ANDA
- Marketing start
- 2014-05-31
- Marketing end
- 0000-00-00
- Substance
- MICONAZOLE NITRATE
- Active strength
- 20 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 49781-064 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 49781-064 | 49781-064-75 | D | Discontinued by firm | 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 | 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 | 49781-064-75 | 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 | 49781-064-75 | 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 | 49781-064-75 | 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 | 49781-064-75 | 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 | 49781-064-75 | 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 | 49781-064-75 | 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 | 49781-064-75 | 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 | 49781-064-75 | ed331223b511… | 672a5bd82f5f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074164-001 | MICONAZOLE 7 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-03-29 |
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 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | cb3db0bc1861… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49781-064-75 | GM - Gram | 49781-064 | 69ca08df-9b0b-4b79-b475-fd7d7df9101e | 1 | 2016-07-19 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| MICONAZOLE NITRATE | ACTIVE INGREDIENT | VW4H1CYW1K | MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [CARDINAL HEALTH (LEADER)] | 1 | |
| MICONAZOLE | ACTIVE MOIETY | 7NNO0D7S5M | MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [CARDINAL HEALTH (LEADER)] | 1 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [CARDINAL HEALTH (LEADER)] | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [CARDINAL HEALTH (LEADER)] | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [CARDINAL HEALTH (LEADER)] | 1 | |
| PEGOXOL 7 STEARATE | INACTIVE INGREDIENT | 3EW5AXE5X5 | MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [CARDINAL HEALTH (LEADER)] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [CARDINAL HEALTH (LEADER)] | 1 |
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 |
|---|---|---|---|---|---|---|
| Miconazole 7 | MICONAZOLE NITRATE | Preferred Pharmaceuticals Inc. | 85a52081-d9cc-44f0-a8d3-851a45c4eb10 | 2026-07-08 | Warnings | 074164 ANDA074164 |
| Miconazole 7 | MICONAZOLE NITRATE | Preferred Pharmaceuticals Inc. | 99c66cbd-7063-4b4c-b827-4f2fcb6ed67f | 2026-07-08 | Warnings | 074164 ANDA074164 |
| Miconazole 7 | MICONAZOLE NITRATE | Walgreens | 0d991104-df96-49b8-b146-67f47b5fcd20 | 2026-06-16 | Warnings | 074164 ANDA074164 |
| Miconazole 7 | MICONAZOLE NITRATE | Family Dollar (FAMILY WELLNESS) | c0249750-551a-4ab3-b5f1-409957889c8e | 2026-03-16 | Warnings | 074164 ANDA074164 |
| Miconazole 7 | MICONAZOLE NITRATE | NuCare Pharmaceuticals,Inc. | 0c055a0d-1031-e7d5-e063-6294a90a17e2 | 2025-02-03 | Warnings | 074164 ANDA074164 |
| Miconazole 7 | MICONAZOLE NITRATE | P & L Development, LLC | facc7b65-0376-445a-8a3d-5180f2f9d5ff | 2024-11-05 | Warnings | 074164 ANDA074164 |
| Miconazole 7 | MICONAZOLE NITRATE | Major Pharmaceuticals | 825ac1c5-470e-4ee1-857d-b205c26fc634 | 2024-10-07 | Warnings | 074164 ANDA074164 |
| Miconazole 7 | MICONAZOLE NITRATE | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 0cef9212-201d-4fd2-8afb-ae06ea6b6ee4 | 2024-09-11 | Warnings | 074164 ANDA074164 |
| Miconazole 7 | MICONAZOLE NITRATE | QUALITY CHOICE (Chain Drug Marketing Association) | 84bef1d3-e4f8-4769-8f94-5ae91ddc9537 | 2024-06-06 | Warnings | 074164 ANDA074164 |
| Miconazole 7 | MICONAZOLE NITRATE | Cardinal Health (Leader) 70000 | 5081411c-02d0-4f7d-8496-d6adccbe00ae | 2024-03-18 | Warnings | 074164 ANDA074164 |
| Miconazole 7 | MICONAZOLE NITRATE | H2-Pharma, LLC | 4bf1a555-a24f-4807-ac13-db19c55cf280 | 2023-01-13 | Warnings | 074164 ANDA074164 |
| Miconazole 7 | MICONAZOLE NITRATE | H2-Pharma, LLC | 67dc7d38-a663-48d5-9abf-b3bd8dc0eddf | 2023-01-13 | Warnings | 074164 ANDA074164 |
| Miconazole 7 | MICONAZOLE NITRATE | QUALITY CHOICE (Chain Drug Marketing Association) | 68667d2e-d4d0-46e7-9d84-0f23fdac1cf7 | 2022-09-30 | Warnings | 074164 ANDA074164 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 49781-064-75 | 49781006475 | 1 TUBE, WITH APPLICATOR in 1 CARTON (49781-064-75) > 45 g in 1 TUBE, WITH APPLICATOR | 2014-05-31 | 0000-00-00 | No | No | Current |