Miconazole 1
- Product NDC
- 0363-0737
- Requested package NDC
- 0363-0737-45
- 11-digit product format
- 003630737
- Labeler code
- 0363
- Product ID
- 0363-0737_c1b93028-7b4e-49fc-bfdb-9c37a0c93a3f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole nitrate
- Dosage form
- KIT
- Labeler
- Walgreen Company
- Application
- ANDA079114
- Marketing category
- ANDA
- Marketing start
- 2010-06-08
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 0363-0737 | 0363-0737-45 | 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… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079114-001 | MICONAZOLE NITRATE | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 |
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 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 2010-06-02 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 2010-06-02 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 2010-06-02 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 2010-06-02 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 2010-06-02 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 2010-06-02 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 2010-06-02 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 2010-06-02 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A079114-001 | MICONAZOLE NITRATE | 2%,1.2GM | CREAM, INSERT / TOPICAL, VAGINAL | 2010-06-02 | cb3db0bc1861… |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-0737-45 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6332-111a-e063-dadaa90a10e2 | Walgreen Co. Miconazole 1 Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0737-45 | Miconazole 1 | 1 in 1 CARTON | KIT | 1 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0363-0737-45 | EA - Each | 0363-0737 | 95037e11-15a7-4694-b72c-2d9dbcb4d970 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 992775 | {1 (miconazole nitrate 1200 MG Vaginal Insert) / 1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) } Pack | GPCK | a9dbcef7-1464-4d72-afb1-d52e070e2994 | 8 |
| 992775 | miconazole 1 day - (1200 MG insert / 2 % cream 9 GM) Pack | PSN | a9dbcef7-1464-4d72-afb1-d52e070e2994 | 8 |
| 992774 | miconazole nitrate 1200 MG Vaginal Insert | PSN | a9dbcef7-1464-4d72-afb1-d52e070e2994 | 8 |
| 998483 | miconazole nitrate 2 % Topical Cream | PSN | a9dbcef7-1464-4d72-afb1-d52e070e2994 | 8 |
| 998540 | miconazole nitrate 2 % Vaginal Cream | PSN | a9dbcef7-1464-4d72-afb1-d52e070e2994 | 8 |
| 992774 | miconazole nitrate 1200 MG Vaginal Insert | SCD | a9dbcef7-1464-4d72-afb1-d52e070e2994 | 8 |
| 998483 | miconazole nitrate 20 MG/ML Topical Cream | SCD | a9dbcef7-1464-4d72-afb1-d52e070e2994 | 8 |
| 998540 | miconazole nitrate 20 MG/ML Vaginal Cream | SCD | a9dbcef7-1464-4d72-afb1-d52e070e2994 | 8 |
| 992774 | miconazole nitrate 1.2 GM Vaginal Insert | SY | a9dbcef7-1464-4d72-afb1-d52e070e2994 | 8 |
| 998483 | miconazole nitrate 2 % Topical Cream | SY | a9dbcef7-1464-4d72-afb1-d52e070e2994 | 8 |
| 998540 | miconazole nitrate 2 % Vaginal Cream | SY | a9dbcef7-1464-4d72-afb1-d52e070e2994 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0363-0737-45 | 00363073745 | 1 KIT in 1 CARTON (0363-0737-45) * 1 SWAB in 1 PACKAGE * 9 g in 1 TUBE * 1 INSERT in 1 POUCH | 1 kit | 2010-06-08 | 0000-00-00 | No | No | Current |