Fosfomycin Tromethamine
- Product NDC
- 82036-4274
- 11-digit product format
- 820364274
- Labeler code
- 82036
- Product ID
- 82036-4274_ea3a4f49-8bac-37c6-e053-2995a90af96b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fosfomycin Tromethamine
- Dosage form
- POWDER
- Route
- ORAL
- Labeler
- Zambon USA, Ltd
- Application
- NDA050717
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2021-08-25
- Marketing end
- 0000-00-00
- Substance
- FOSFOMYCIN TROMETHAMINE
- Active strength
- 3 g/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 82036-4274 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 82036-4274 | 82036-4274-1 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 82036-4274 | 82036-4274-8 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| N050717-001 | MONUROL | FOSFOMYCIN TROMETHAMINE | EQ 3GM BASE/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | | RLD | 1996-12-19 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82036-4274 | FOSFOMYCIN TROMETHAMINE POWDER [ZAMBON USA, LTD] | 6 | Legacy NDC | 20231004_ca668546-c8ba-af0a-e053-2995a90a2300.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 82036-4274-1 | 82036427401 | 1 DOSE PACK in 1 CARTON (82036-4274-1) > 1 POWDER in 1 DOSE PACK | 1 dose pack | 2021-08-25 | 0000-00-00 | No | No | Current |
| 82036-4274-8 | 82036427408 | 1 POWDER in 1 PACKET (82036-4274-8) | 1 powder | 2021-08-25 | 0000-00-00 | No | No | Current |