Phentermine Hydrochloride

Product NDC
17224-703
11-digit product format
172240703
Labeler code
17224
Product ID
17224-703_7dc029c3-3797-4bd7-b075-a0a5dd68aa0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
CALVIN, SCOTT AND COMPANY, INCORPORATED
Application
ANDA040555
Marketing category
ANDA
Marketing start
2005-04-15
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
38 mg/1
Pharmacologic classes
Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17224-703IInactivated by FDA2026-08-07
excluded packagepackage17224-70317224-703-10IInactivated by FDA2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 38 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17224-703-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17224-703-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17224-703-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17224-703-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17224-703-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17224-703-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17224-703-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17224-703-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17224-703-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17224-703-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17224-703-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17224-703-10557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage17224-703-108af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17224-703-10834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17224-703-101332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage17224-703-10fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage17224-703-1086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage17224-703-10bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage17224-703-108dfbde2a14a4…c9ff85d89658…

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
A040555-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-153f01610625f2…
2019-09-15 20:21 UTC2019-09A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-15cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040555-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040555-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040555-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040555-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040555-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040555-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040555-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040555-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040555-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040555-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040555-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040555-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040555-001AA1ea99ee380514…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040555-001AA1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303
32c2b0bd-1f13-4890-99e0-dcd2ea16e1abProduct name220230717
ebeae3eb-385d-62da-8827-5ffa80b14e90Product name220170810
1d682039-1122-1cb7-f3f4-c0a028b98748Product name420170124
8ef9ca65-1a6c-7225-351d-36066d0f8e56Product name320161229

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17224-703-10Phentermine Hydrochloride28 in 1 BOTTLETABLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17224-703PHENTERMINE HYDROCHLORIDE TABLET [CALVIN, SCOTT AND COMPANY, INCORPORATED]2Legacy NDC, 1 package rows20191120_d0663bfb-810c-44f9-acc1-3166fe6eedde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSNd0663bfb-810c-44f9-acc1-3166fe6eedde2
803353phentermine hydrochloride 37.5 MG Oral TabletSCDd0663bfb-810c-44f9-acc1-3166fe6eedde2
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYd0663bfb-810c-44f9-acc1-3166fe6eedde2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
17224-703-101722407031028 in 1 BOTTLEHistorical