benzphetamine hydrochloride
- Product NDC
- 43547-263
- 11-digit product format
- 435470263
- Labeler code
- 43547
- Product ID
- 43547-263_48be1cda-69dc-46d9-a2c4-55d4a5ef04fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benzphetamine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Solco Healthcare US LLC
- Application
- ANDA090473
- Marketing category
- ANDA
- Marketing start
- 2011-08-01
- Marketing end
- 0000-00-00
- Substance
- BENZPHETAMINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
- 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 | 43547-263 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 43547-263 | 43547-263-10 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 43547-263 | 43547-263-50 | 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 |
FDA-Initiated Inactive NDC Indexing#