Regimex
- Product NDC
- 66992-399
- 11-digit product format
- 669920399
- Labeler code
- 66992
- Product ID
- 66992-399_1a5d7233-4453-42a5-8144-a4276db39660
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benzphetamine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Wraser Pharmaceuticals
- Application
- ANDA090473
- Marketing category
- ANDA
- Marketing start
- 2013-02-01
- Marketing end
- 0000-00-00
- Substance
- BENZPHETAMINE H
- Active strength
- 25 mg/1
- Pharmacologic classes
- Appetite Suppre
- DEA schedule
- CIII
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 | 66992-399 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 66992-399 | 66992-399-10 | 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 |
|---|
| A090473-001 | BENZPHETAMINE HYDROCHLORIDE | BENZPHETAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | | | 2010-09-15 |
| A090473-002 | BENZPHETAMINE HYDROCHLORIDE | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | | 2010-09-15 |
Therapeutic equivalence codes#
Application-product, TE code table| Application-product | TE code |
|---|
| A090473-002 | AA |