Phentermine hydrochloride

Product NDC
17224-904
Requested package NDC
17224-904-28
11-digit product format
172240904
Labeler code
17224
Product ID
17224-904_f6e232c2-4182-6274-e053-6294a90a5e38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENTERMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Calvin Scott & Co., Inc.
Application
ANDA205008
Marketing category
ANDA
Marketing start
2017-01-24
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
37.5 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
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…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
A205008-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205008-001AA

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 · 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 UTC2026-02A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-253f01610625f2…
2019-09-15 20:21 UTC2019-09A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205008-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-09-25cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205008-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205008-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205008-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205008-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205008-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205008-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205008-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205008-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205008-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205008-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205008-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205008-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205008-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205008-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205008-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205008-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205008-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205008-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205008-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205008-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205008-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A205008-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205008-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205008-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205008-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A205008-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205008-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205008-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205008-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205008-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205008-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205008-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205008-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205008-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205008-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205008-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205008-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205008-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205008-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205008-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE37.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0K2I505OTVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
803353Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3d1d4dde-1c7f-4a20-b8f8-897b1b284f80Available on FDA.report

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#

Effective, Related label table
EffectiveRelated label
2023-03-15These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. PHENTERMINE hydrochloride capsules USP, for oral use CIV PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959
2023-03-15These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. PHENTERMINE hydrochloride capsules USP, for oral use CIV PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959
2021-01-29These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. PHENTERMINE hydrochloride capsules USP, for oral use CIV PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959
2021-01-29These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. PHENTERMINE hydrochloride capsules USP, for oral use CIV PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17224-904-07Phentermine hydrochloride7 in 1 BOTTLETABLET72
17224-904-28Phentermine hydrochloride28 in 1 BOTTLETABLET282
17224-904-30Phentermine hydrochloride30 in 1 BOTTLETABLET302
17224-904-60Phentermine hydrochloride60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17224-904PHENTERMINE HYDROCHLORIDE TABLET [CALVIN SCOTT & CO., INC.]2Current NDC, Legacy NDC, 4 package rows20230316_3d1d4dde-1c7f-4a20-b8f8-897b1b284f80.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.3d1d4dde-1c7f-4a20-b8f8-897b1b284f802026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205008
application number: ANDA205008
ndc (package): 17224-904-28
ndc (product): 17224-904
ndc11 (package): 17224090428
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack9155edf8-ea1d-458f-b2a7-e0303fd83cc02026-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205008
application number: ANDA205008
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.129e781c-5366-4986-8e67-6b35fa4c3f392025-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205008
application number: ANDA205008
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacke08b4f49-de9f-490d-b11d-d865439f5fad2025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205008
application number: ANDA205008
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacke0a6a289-7dbf-4b24-b815-46dee0d19fdc2025-01-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205008
application number: ANDA205008
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack99c1325b-7152-481d-8a1f-6bf3e2c4808b2025-01-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205008
application number: ANDA205008
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDESUNRISE PHARMACEUTICAL, INC.43024f64-2d77-49a9-80fd-ad07a86c69a32024-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205008
application number: ANDA205008
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack50efa498-11c5-41fa-95ac-419fcc10da032024-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205008
application number: ANDA205008
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.1fa8798d-c096-5839-e063-6394a90aa28b2024-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205008
application number: ANDA205008
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LP28fda2ce-d445-47ce-8764-bf113b5db5b32022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205008
application number: ANDA205008
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEAsclemed USA, Inc.de76ed27-ac43-4923-b73f-461d33941f6b2020-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205008
application number: ANDA205008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN3d1d4dde-1c7f-4a20-b8f8-897b1b284f803
803353phentermine hydrochloride 37.5 MG Oral TabletSCD3d1d4dde-1c7f-4a20-b8f8-897b1b284f803
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY3d1d4dde-1c7f-4a20-b8f8-897b1b284f803

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17224-904-281722409042828 TABLET in 1 BOTTLE (17224-904-28) 28 tablet2017-01-24NoNoCurrent