Phentermine Hydrochloride

Product NDC
50090-0415
Requested package NDC
50090-0415-0
11-digit product format
500900415
Labeler code
50090
Product ID
50090-0415_9903e654-1d2b-47bd-b457-ee3f78271c4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
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
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-041550090-0415-0IInactivated 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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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#

NDC, Related label table
NDCRelated label
50090-0415-0These highlights do not include all the information needed to use phentermine hydrochloride capsules, USP safely and effectively. See full prescribing information for phentermine hydrochloride capsules, USP. PHENTERMINE Hydrochloride Capsules, USP for oral use CIV Initial U.S. Approval: 1959
50090-0415-2These highlights do not include all the information needed to use phentermine hydrochloride capsules, USP safely and effectively. See full prescribing information for phentermine hydrochloride capsules, USP. PHENTERMINE Hydrochloride Capsules, USP for oral use CIV Initial U.S. Approval: 1959
50090-0415-3These highlights do not include all the information needed to use phentermine hydrochloride capsules, USP safely and effectively. See full prescribing information for phentermine hydrochloride capsules, USP. PHENTERMINE Hydrochloride Capsules, USP for oral use CIV Initial U.S. Approval: 1959
50090-0415-4These highlights do not include all the information needed to use phentermine hydrochloride capsules, USP safely and effectively. See full prescribing information for phentermine hydrochloride capsules, USP. PHENTERMINE Hydrochloride Capsules, USP for oral use CIV Initial U.S. Approval: 1959
50090-0415-6These highlights do not include all the information needed to use phentermine hydrochloride capsules, USP safely and effectively. See full prescribing information for phentermine hydrochloride capsules, USP. PHENTERMINE Hydrochloride Capsules, USP for oral use CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0415-0Phentermine Hydrochloride30 in 1 BOTTLECAPSULE3016
50090-0415-2Phentermine Hydrochloride90 in 1 BOTTLECAPSULE9016
50090-0415-3Phentermine Hydrochloride14 in 1 BOTTLECAPSULE1416
50090-0415-4Phentermine Hydrochloride60 in 1 BOTTLECAPSULE6016
50090-0415-6Phentermine Hydrochloride28 in 1 BOTTLECAPSULE2816

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0415-0EA - Each50090-0415d16362ce-7db1-4488-8450-8b3aea8bee6312018-09-05
50090-0415-3EA - Each50090-0415c24d71e6-1a07-441f-b765-a295bcec6a1712018-09-05
50090-0415-6EA - Each50090-04153575bbde-26b4-4b3c-8476-ddbd4f75c29112018-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0415PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]16Legacy NDC, 5 package rows20200714_1c0195e8-902e-4c73-86e5-0197122154ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN1c0195e8-902e-4c73-86e5-0197122154ed16
900038phentermine hydrochloride 30 MG Oral CapsuleSCD1c0195e8-902e-4c73-86e5-0197122154ed16
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY1c0195e8-902e-4c73-86e5-0197122154ed16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0415-05009004150030 CAPSULE in 1 BOTTLE (50090-0415-0) 30 capsule2014-11-280000-00-00NoNoCurrent