Phentermine Hydrochloride

Product NDC
53217-330
11-digit product format
532170330
Labeler code
53217
Product ID
53217-330_6a5bb1f1-c1d7-4d44-9bba-4783dd6719bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA087022
Marketing category
ANDA
Marketing start
2007-12-01
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
30 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
2019-12-31
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 productproduct53217-330IInactivated by FDA2026-08-07
excluded packagepackage53217-33053217-330-14IInactivated 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 · 42 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 packagepackage53217-330-14d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53217-330-14f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53217-330-142ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53217-330-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53217-330-14cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53217-330-14cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53217-330-14302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53217-330-14ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53217-330-140efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53217-330-14ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53217-330-14367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53217-330-14557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53217-330-148af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53217-330-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53217-330-141332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53217-330-14fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53217-330-1486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53217-330-14bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53217-330-148dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53217-330-14e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53217-330-149bebd1f3094a…5416666fcb17…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A087022-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORAL1983-02-03
A087022-002PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORAL2012-01-20

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORAL1983-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORAL2012-01-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORAL1983-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORAL2012-01-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORAL1983-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORAL2012-01-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORAL1983-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORAL2012-01-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORAL1983-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORAL2012-01-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORAL1983-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORAL2012-01-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORAL1983-02-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORAL2012-01-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORAL1983-02-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORAL2012-01-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORAL1983-02-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORAL2012-01-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORAL1983-02-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORAL2012-01-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORAL1983-02-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORAL2012-01-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORAL1983-02-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORAL2012-01-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORAL1983-02-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORAL2012-01-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORAL1983-02-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORAL2012-01-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA1983-02-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-01-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA1983-02-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-01-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA1983-02-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-01-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA1983-02-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-01-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA1983-02-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-01-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087022-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA1983-02-03782e0a99824c…
2021-12-28 21:50 UTC2021-12A087022-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-01-20782e0a99824c…

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 ZIP2022-06A087022-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087022-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087022-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A087022-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087022-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A087022-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087022-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A087022-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087022-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A087022-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087022-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A087022-002AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087022-001AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087022-002AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A087022-001AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A087022-002AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087022-001AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A087022-002AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087022-001AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A087022-002AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087022-001AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A087022-002AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A087022-001AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A087022-002AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A087022-001AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A087022-002AA1ea99ee380514…
2023-01-26 05:58 UTC2023-01A087022-001AA13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A087022-002AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087022-001AA13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087022-002AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087022-001AA1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A087022-002AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087022-001AA1e64feba35796…
2022-09-29 23:25 UTC2022-09A087022-002AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087022-001AA1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087022-002AA1cb3db0bc1861…

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
53217-330-14Phentermine Hydrochloride14 in 1 BOTTLECAPSULE141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-330PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180530_c8b12e5c-00c9-46e9-943b-c2908113f5bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSNc8b12e5c-00c9-46e9-943b-c2908113f5bd1
900038phentermine hydrochloride 30 MG Oral CapsuleSCDc8b12e5c-00c9-46e9-943b-c2908113f5bd1
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYc8b12e5c-00c9-46e9-943b-c2908113f5bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-330-145321703301414 in 1 BOTTLEHistorical