FDA.reportPublic FDA data

Benzphetamine Hydrochloride

Product NDC
50090-5837
Requested package NDC
50090-5837-2
11-digit product format
500905837
Labeler code
50090
Product ID
50090-5837_06aa2799-9910-4cbd-b44f-50755a51536e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzphetamine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090346
Marketing category
ANDA
Marketing start
2015-12-16
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
No
Listing certified through
2022-12-31
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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-583750090-5837-2DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090346-001BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2015-12-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A090346-001AA

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090346-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2015-12-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090346-001AA1a50c72e98297…

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benzphetamine HydrochlorideBENZPHETAMINE HYDROCHLORIDEEpic Pharma, LLCf6d9b369-4b64-4d3f-844d-5d60dd257c552023-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090346
application number: ANDA090346

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5837-12023-02-07C16284748780-1f386c64a-4024-0266-e053-dadaa90a7c1aBenzphetamine Hydrochloride Tablets, CIII Rx Only
50090-5837-22023-02-07C16284748780-1f386c64a-4024-0266-e053-dadaa90a7c1aBenzphetamine Hydrochloride Tablets, CIII Rx Only
50090-5837-12023-01-30C16284748780-1f386c64a-4024-0266-e053-dadaa90a7c1aBenzphetamine Hydrochloride Tablets, CIII Rx Only
50090-5837-22023-01-30C16284748780-1f386c64a-4024-0266-e053-dadaa90a7c1aBenzphetamine Hydrochloride Tablets, CIII Rx Only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5837-1EA - Each50090-5837b84e1314-18db-4056-b737-729e6875d5ee12022-07-06
50090-5837-2EA - Each50090-5837e482f36c-1efd-4eb1-92a5-0aefce18340312022-07-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5837-25009058370290 TABLET, FILM COATED in 1 BOTTLE (50090-5837-2) 2021-11-020000-00-00NoNoCurrent