PHENDIMETRAZINE TARTRATE

Product NDC
72162-2044
11-digit product format
721622044
Labeler code
72162
Product ID
72162-2044_206296be-2b0a-43af-8927-d8189d0af96d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phendimetrazine Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040762
Marketing category
ANDA
Marketing start
2012-11-20
Substance
PHENDIMETRAZINE TARTRATE
Active strength
35 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
A040762-001PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040762-001AA

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 06:07:402026-07A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-283f01610625f2…
2019-09-15 20:21 UTC2019-09A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040762-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2008-01-28e64feba35796…

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 06:07:402026-07A040762-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040762-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040762-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040762-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040762-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040762-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040762-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040762-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040762-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040762-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040762-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040762-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040762-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040762-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040762-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040762-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040762-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040762-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040762-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040762-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040762-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040762-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040762-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040762-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040762-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040762-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040762-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040762-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040762-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040762-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040762-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040762-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040762-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040762-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040762-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040762-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040762-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040762-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040762-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040762-001AA1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
PHENDIMETRAZINE TARTRATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENDIMETRAZINE TARTRATE35 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6985IP0T80Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
979549Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8593421c-d1fb-409d-a5bb-3369da18fd2cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
71525015-bcb9-5864-7749-4b5f528a6b6aProduct name220180419
977c925f-5460-67b1-e843-25a0ba370df1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2044-0PHENDIMETRAZINE TARTRATE1000 in 1 BOTTLETABLET1000102
72162-2044-1PHENDIMETRAZINE TARTRATE100 in 1 BOTTLETABLET100102
72162-2044-3PHENDIMETRAZINE TARTRATE30 in 1 BOTTLETABLET30102
72162-2044-6PHENDIMETRAZINE TARTRATE60 in 1 BOTTLETABLET60102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2044-0EA - Each72162-2044b0f89e9c-189f-42b0-98fd-e0237c13dc8d12023-08-08
72162-2044-1EA - Each72162-2044d9fa1eb5-652b-4c96-92bf-7b0311129d2912023-08-08
72162-2044-3EA - Each72162-204483e303a9-8f8f-4035-b0f3-18d9f9fd8e0712023-08-08
72162-2044-6EA - Each72162-2044c2de6b24-ac93-4e34-9822-85e48a05030712023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2044PHENDIMETRAZINE TARTRATE TABLET [BRYANT RANCH PREPACK]102Current NDC, 4 package rows20230713_8593421c-d1fb-409d-a5bb-3369da18fd2c.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATENuCare Pharmaceuticals,Inc.05bb0569-4eed-2139-e063-6394a90acb6c2024-09-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040762
application number: ANDA040762
PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEBryant Ranch Prepack8593421c-d1fb-409d-a5bb-3369da18fd2c2023-07-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040762
application number: ANDA040762
ndc (product): 72162-2044
PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATEElite Laboratories, Inc42ecacde-6859-47c6-ba44-13fb4f3b54482019-02-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040762
application number: ANDA040762

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979549phendimetrazine tartrate 35 MG Oral TabletPSN8593421c-d1fb-409d-a5bb-3369da18fd2c102
979549phendimetrazine tartrate 35 MG Oral TabletSCD8593421c-d1fb-409d-a5bb-3369da18fd2c102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2044-0721622044001000 TABLET in 1 BOTTLE (72162-2044-0) 1000 tablet2023-06-14NoNoCurrent
72162-2044-172162204401100 TABLET in 1 BOTTLE (72162-2044-1) 100 tablet2023-06-14NoNoCurrent
72162-2044-37216220440330 TABLET in 1 BOTTLE (72162-2044-3) 30 tablet2023-06-14NoNoCurrent
72162-2044-67216220440660 TABLET in 1 BOTTLE (72162-2044-6) 60 tablet2023-06-14NoNoCurrent