Phendimetrazine Tartrate
- Product NDC
- 50090-0338
- 11-digit product format
- 500900338
- Labeler code
- 50090
- Product ID
- 50090-0338_37f401b5-c31a-4871-aeba-9b1db9a9ecf1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phendimetrazine Tartrate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- NDA018074
- Marketing category
- NDA
- Marketing start
- 1977-09-06
- Marketing end
- 0000-00-00
- Substance
- PHENDIMETRAZINE TARTRATE
- Active strength
- 105 mg/1
- Pharmacologic classes
- Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 50090-0338 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 50090-0338 | 50090-0338-0 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 50090-0338 | 50090-0338-1 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018074-001 | PHENDIMETRAZINE TARTRATE | PHENDIMETRAZINE TARTRATE | 105MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS, 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N018074-001 | PHENDIMETRAZINE TARTRATE | 105MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS, Approved before 1982 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PHENDIMETRAZINE TARTRATE | PHENDIMETRAZINE TARTRATE | Acertis Pharmaceuticals, LLC | 162140d3-b833-4633-9759-95821a46a690 | 2025-12-19 | Warnings, Adverse reactions | 018074 NDA018074 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-0338-1 | EA - Each | 50090-0338 | 7db3e725-1fa6-42e0-9e16-e8fad2f3ac95 | 1 | 2018-11-06 |