Benzphetamine Hydrochloride

Product NDC
23155-952
11-digit product format
231550952
Labeler code
23155
Product ID
23155-952_e359f1ec-c10f-4752-9b9a-c2fd120c4356
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzphetamine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA202061
Marketing category
ANDA
Marketing start
2026-06-19
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A202061-001BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2012-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202061-001AA

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2012-01-2784e616aacf4f…
2026-08-18 06:07:402026-07A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2012-01-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2012-01-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2012-01-273f01610625f2…
2019-09-15 20:21 UTC2019-09A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2012-01-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAA2012-01-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202061-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2012-01-27f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202061-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A202061-001AA1caaa826d4ba7…
2019-12-13 00:20 UTC2019-12A202061-001AA174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A202061-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A202061-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202061-001AA1ea99ee380514…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202061-001AA1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Benzphetamine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZPHETAMINE HYDROCHLORIDE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
43DWT87QT7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
904368Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
152a123e-4886-4184-a47d-462ce102b8faAvailable on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benzphetamine HydrochlorideBENZPHETAMINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.152a123e-4886-4184-a47d-462ce102b8fa2026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202061
application number: ANDA202061
ndc (product): 23155-952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
23155-952-0123155095201100 TABLET, FILM COATED in 1 BOTTLE (23155-952-01) 2026-06-19NoNoCurrent
23155-952-032315509520330 TABLET, FILM COATED in 1 BOTTLE (23155-952-03) 2026-06-19NoNoCurrent
23155-952-0523155095205500 TABLET, FILM COATED in 1 BOTTLE (23155-952-05) 2026-06-19NoNoCurrent