Phentermine Hydrochloride

Product NDC
66336-344
11-digit product format
663360344
Labeler code
66336
Product ID
66336-344_9705bec8-2f8d-4aa0-9009-7b4e83077958
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA040527
Marketing category
ANDA
Marketing start
2003-10-23
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
E
Listing certified through
2017-12-31
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 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66336-344IInactivated by FDA2026-08-07
excluded packagepackage66336-34466336-344-07IInactivated by FDA2026-08-07
excluded packagepackage66336-34466336-344-14IInactivated by FDA2026-08-07
excluded packagepackage66336-34466336-344-15IInactivated by FDA2026-08-07
excluded packagepackage66336-34466336-344-28IInactivated by FDA2026-08-07
excluded packagepackage66336-34466336-344-30IInactivated by FDA2026-08-07
excluded packagepackage66336-34466336-344-45IInactivated by FDA2026-08-07
excluded packagepackage66336-34466336-344-56IInactivated by FDA2026-08-07
excluded packagepackage66336-34466336-344-60IInactivated by FDA2026-08-07
excluded packagepackage66336-34466336-344-84IInactivated 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 4 · 220 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 packagepackage66336-344-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-344-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-344-84d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-344-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-344-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-344-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-344-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-344-56d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-344-45d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-344-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-344-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-344-84f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-344-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-344-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-344-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-344-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-344-56f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-344-45f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-344-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-344-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-344-842ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-344-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-344-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-344-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-344-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-344-562ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-344-452ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-344-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-344-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-344-84a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-344-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-344-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-344-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-344-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-344-56a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-344-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-344-28cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-344-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-344-84cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-344-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-344-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-344-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-344-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-344-56cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-344-45cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-344-28cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-344-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-344-84cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-344-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-344-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-344-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-344-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-344-56cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-344-45cdf11ea48f46…ba0047e9e063…

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
A040527-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23

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 UTC2026-02A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-233f01610625f2…
2019-09-15 20:21 UTC2019-09A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040527-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORAL2003-10-23cb3db0bc1861…

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
66336-344-07Phentermine Hydrochloride7 in 1 BOTTLETABLET71
66336-344-14Phentermine Hydrochloride14 in 1 BOTTLETABLET141
66336-344-15Phentermine Hydrochloride15 in 1 BOTTLETABLET151
66336-344-28Phentermine Hydrochloride28 in 1 BOTTLETABLET281
66336-344-30Phentermine Hydrochloride30 in 1 BOTTLETABLET301
66336-344-45Phentermine Hydrochloride45 in 1 BOTTLETABLET451
66336-344-56Phentermine Hydrochloride56 in 1 BOTTLETABLET561
66336-344-60Phentermine Hydrochloride60 in 1 BOTTLETABLET601
66336-344-84Phentermine Hydrochloride84 in 1 BOTTLETABLET841

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66336-344-07EA - Each66336-344e0d57e4d-bddd-4cdc-ad72-01a3882ffbe012012-07-24
66336-344-14EA - Each66336-34461489994-b692-4936-9636-5976c8bf7c6912012-07-24
66336-344-28EA - Each66336-3441d71651b-5445-4b11-b31c-01ac97382c7712012-07-24
66336-344-30EA - Each66336-344d537438c-f65b-4f61-8841-4419c17b4c8012012-07-24
66336-344-56EA - Each66336-34486ced4e1-f90d-4ea4-b31b-703cec3c99de12012-07-24
66336-344-84EA - Each66336-344207c81ee-484a-4423-af7b-a518207e33eb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phentermine HydrochlorideACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]1
PhentermineACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]1
povidoneINACTIVE INGREDIENTFZ989GH94EPHENTERMINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-344PHENTERMINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 9 package rows20120213_d60075f0-19b9-410d-b93b-d897de08f5a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSNd60075f0-19b9-410d-b93b-d897de08f5a51
803353phentermine hydrochloride 37.5 MG Oral TabletSCDd60075f0-19b9-410d-b93b-d897de08f5a51
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYd60075f0-19b9-410d-b93b-d897de08f5a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-344-07663360344077 in 1 BOTTLEHistorical
66336-344-146633603441414 in 1 BOTTLEHistorical
66336-344-156633603441515 in 1 BOTTLEHistorical
66336-344-286633603442828 in 1 BOTTLEHistorical
66336-344-306633603443030 in 1 BOTTLEHistorical
66336-344-456633603444545 in 1 BOTTLEHistorical
66336-344-566633603445656 in 1 BOTTLEHistorical
66336-344-606633603446060 in 1 BOTTLEHistorical
66336-344-846633603448484 in 1 BOTTLEHistorical