Phentermine Hydrochloride

Product NDC
17224-901
Requested package NDC
17224-901-28
11-digit product format
172240901
Labeler code
17224
Product ID
17224-901_4a195805-16d2-9214-e063-6394a90ac691
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENTERMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Calvin Scott & Co., Inc.
Application
ANDA040526
Marketing category
ANDA
Marketing start
2013-08-12
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
2027-12-31
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17224-90117224-901-28EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17224-90117224-901-28EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
A040526-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040526-001AA

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 UTC2026-02A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-233f01610625f2…
2019-09-15 20:21 UTC2019-09A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23cb3db0bc1861…

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 UTC2026-02A040526-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040526-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040526-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040526-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040526-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040526-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040526-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040526-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040526-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040526-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040526-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040526-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040526-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040526-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040526-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040526-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040526-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040526-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040526-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040526-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040526-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040526-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040526-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040526-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040526-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040526-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040526-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040526-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040526-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040526-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040526-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040526-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040526-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040526-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040526-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040526-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040526-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040526-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040526-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040526-001AA1cb3db0bc1861…

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
aa9d7161-cda3-4ded-8d5b-424abd1a6681Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17224-901-07Phentermine Hydrochloride7 in 1 BOTTLE, PLASTICTABLET72
17224-901-14Phentermine Hydrochloride14 in 1 BOTTLE, PLASTICTABLET142
17224-901-28Phentermine Hydrochloride28 in 1 BOTTLE, PLASTICTABLET282
17224-901-30Phentermine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302
17224-901-45Phentermine Hydrochloride45 in 1 BOTTLE, PLASTICTABLET452
17224-901-60Phentermine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET602
17224-901-90Phentermine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17224-901PHENTERMINE HYDROCHLORIDE TABLET [CALVIN SCOTT & CO., INC.]1Current NDC, 7 package rows20250523_aa9d7161-cda3-4ded-8d5b-424abd1a6681.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HCL C-IVPHENTERMINE HCL C-IVDirect_Rx4cec0e47-5373-2133-e063-6394a90a20092026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.aa9d7161-cda3-4ded-8d5b-424abd1a66812026-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
ndc (package): 17224-901-28
ndc (product): 17224-901
ndc11 (package): 17224090128
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions0e893b62-bb07-4984-9f0a-3601435fbc272026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENorthwind Health Company, LLC1b5396a8-e7ef-45ae-e063-6294a90a14a22025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.abf702d6-6f94-48dc-ad23-c52fd74e83a82025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.12699287-9ca9-07b3-e063-6294a90af21a2025-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.02b8f684-b1ca-4ab7-9567-bcacc6a927792025-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.312d9742-6a65-c1cb-e063-6394a90a2e662025-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8abf898e-318b-3519-e053-2995a90abf2f2024-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack53cad049-f1b4-42c0-9cc7-a1c2df75ac582024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack0ca26b58-0a93-4a10-be4d-63a4ad5eecf82024-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackac8559a0-98fe-4737-b9ec-e36eef3b14fc2024-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackc5d60a6d-2410-4a3c-88e1-a6126b56cf6a2024-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack95f908c2-1003-4e8f-8e4a-86f4934568782024-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack83802088-f4fc-4b34-9268-d63fb2ad16552023-09-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LPb14a8f6a-a1c6-4104-80f2-0fa35320d04c2023-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSNaa9d7161-cda3-4ded-8d5b-424abd1a66812
803353phentermine hydrochloride 37.5 MG Oral TabletSCDaa9d7161-cda3-4ded-8d5b-424abd1a66812
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYaa9d7161-cda3-4ded-8d5b-424abd1a66812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17224-901-281722409012828 TABLET in 1 BOTTLE, PLASTIC (17224-901-28) 28 tablet2013-08-12NoNoCurrent