Fluoroplex
- Product NDC
- 16110-812
- 11-digit product format
- 161100812
- Labeler code
- 16110
- Product ID
- 16110-812_0d7ce07c-d2a5-4d78-adb9-c7196c6cb3a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluorouracil
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Almirall, LLC
- Application
- NDA016988
- Marketing category
- NDA
- Marketing start
- 1993-12-03
- Marketing end
- 0000-00-00
- Substance
- FLUOROURACIL
- Active strength
- 10 mg/g
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
- 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 | 16110-812 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 16110-812 | 16110-812-30 | 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 16110-812-30 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 16110-812-30 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 16110-812-30 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 16110-812-30 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 16110-812-30 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 16110-812-30 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 16110-812-30 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 16110-812-30 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 16110-812-30 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 16110-812-30 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 16110-812-30 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 16110-812-30 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 16110-812-30 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 16110-812-30 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 16110-812-30 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N016988-001 | FLUOROPLEX | FLUOROURACIL | 1% | CREAM / TOPICAL | RLD, Approved before 1982 |
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 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, RS, Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, RS, Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, RS, Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, RS, Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, RS, Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, RS, Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, RS, Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, RS, Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N016988-001 | FLUOROPLEX | 1% | CREAM / TOPICAL | RLD, Approved before 1982 | e64feba35796… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 16110-812-30 | 2025-11-13 | C162847 | 48780-1 | 1030e364-fb48-111a-e063-dadaa90a10e2 | FLUOROPLEX (fluorouracil) 1% Topical Cream |
| 16110-812-30 | 2024-01-30 | C162847 | 48780-1 | 1030e364-fb48-111a-e063-dadaa90a10e2 | FLUOROPLEX (fluorouracil) 1% Topical Cream |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16110-812-30 | GM - Gram | 16110-812 | da8b9fcc-7cd2-4c4a-8348-59906f645ee1 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| fluorouracil | ACTIVE INGREDIENT | U3P01618RT | FLUOROPLEX (FLUOROURACIL) CREAM [AQUA PHARMACEUTICALS, LLC] | 1 | |
| fluorouracil | ACTIVE MOIETY | U3P01618RT | FLUOROPLEX (FLUOROURACIL) CREAM [AQUA PHARMACEUTICALS, LLC] | 1 | |
| benzyl alcohol | INACTIVE INGREDIENT | LKG8494WBH | FLUOROPLEX (FLUOROURACIL) CREAM [AQUA PHARMACEUTICALS, LLC] | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | FLUOROPLEX (FLUOROURACIL) CREAM [AQUA PHARMACEUTICALS, LLC] | 1 | |
| mineral oil | INACTIVE INGREDIENT | T5L8T28FGP | FLUOROPLEX (FLUOROURACIL) CREAM [AQUA PHARMACEUTICALS, LLC] | 1 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | FLUOROPLEX (FLUOROURACIL) CREAM [AQUA PHARMACEUTICALS, LLC] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | FLUOROPLEX (FLUOROURACIL) CREAM [AQUA PHARMACEUTICALS, LLC] | 1 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 16110-812-30 | 16110081230 | 1 TUBE in 1 CARTON (16110-812-30) > 30 g in 1 TUBE | 1 tube | 1993-12-03 | 0000-00-00 | No | No | Current |