benzphetamine hydrochloride

Product NDC
17224-672
11-digit product format
172240672
Labeler code
17224
Product ID
17224-672_f5ee265f-9765-de77-e053-2a95a90ac76f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZPHETAMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Calvin Scott & Co., Inc.
Application
ANDA090968
Marketing category
ANDA
Marketing start
2010-01-01
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A090968-001BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090968-001AA

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-203f01610625f2…
2019-09-15 20:21 UTC2019-09A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090968-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORALAARS2010-07-20e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090968-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090968-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090968-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090968-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090968-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090968-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090968-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090968-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090968-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090968-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090968-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090968-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090968-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090968-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090968-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090968-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090968-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090968-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090968-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090968-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090968-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090968-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090968-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090968-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090968-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090968-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A090968-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090968-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090968-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090968-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090968-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090968-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090968-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090968-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090968-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090968-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090968-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090968-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090968-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090968-001AA1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
benzphetamine hydrochloride
Listing expiration
2026-12-31

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
f5c3c2ed-54a2-1def-e053-2995a90ab4e3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e1de3598-2dc1-55e2-fc07-ee2e74c73cfcProduct name320201013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17224-672-30benzphetamine hydrochloride30 in 1 BOTTLE, PLASTICTABLET302
17224-672-60benzphetamine hydrochloride60 in 1 BOTTLE, PLASTICTABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17224-672BENZPHETAMINE HYDROCHLORIDE TABLET [CALVIN SCOTT & CO., INC.]2Current NDC, 2 package rows20230303_f5c3c2ed-54a2-1def-e053-2995a90ab4e3.zip

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDEKVK-TECH, INC14d4589d-7f1c-4b6e-9557-59dad39b09602026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090968
application number: ANDA090968
BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2b7014af-0cc9-4199-90f2-ec07ac02f8cf2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090968
application number: ANDA090968
BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDEBryant Ranch Prepack1c726aa7-3b78-45de-aca0-fd8a5fff94032024-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090968
application number: ANDA090968
benzphetamine hydrochlorideBENZPHETAMINE HYDROCHLORIDECalvin Scott & Co., Inc.f5c3c2ed-54a2-1def-e053-2995a90ab4e32023-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090968
application number: ANDA090968
ndc (product): 17224-672

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904368benzphetamine HCl 50 MG Oral TabletPSNf5c3c2ed-54a2-1def-e053-2995a90ab4e32
904368benzphetamine hydrochloride 50 MG Oral TabletSCDf5c3c2ed-54a2-1def-e053-2995a90ab4e32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17224-672-301722406723030 TABLET in 1 BOTTLE, PLASTIC (17224-672-30) 30 tablet2010-01-01NoNoCurrent
17224-672-601722406726060 TABLET in 1 BOTTLE, PLASTIC (17224-672-60) 60 tablet2010-01-01NoNoCurrent