Phentermine Hydrochloride

Product NDC
52959-812
11-digit product format
529590812
Labeler code
52959
Product ID
52959-812_61e4300d-6f7e-6951-e053-2a91aa0a974a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA203068
Marketing category
ANDA
Marketing start
2017-07-18
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
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 14 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-812IInactivated by FDA2026-08-03
excluded productproduct52959-812IInactivated by FDA2026-08-03
excluded packagepackage52959-81252959-812-07IInactivated by FDA2026-08-03
excluded packagepackage52959-81252959-812-10IInactivated by FDA2026-08-03
excluded packagepackage52959-81252959-812-11IInactivated by FDA2026-08-03
excluded packagepackage52959-81252959-812-14IInactivated by FDA2026-08-03
excluded packagepackage52959-81252959-812-20IInactivated by FDA2026-08-03
excluded packagepackage52959-81252959-812-22IInactivated by FDA2026-08-03
excluded packagepackage52959-81252959-812-28IInactivated by FDA2026-08-03
excluded packagepackage52959-81252959-812-30IInactivated by FDA2026-08-03
excluded packagepackage52959-81252959-812-60IInactivated by FDA2026-08-03
excluded packagepackage52959-81252959-812-90IInactivated by FDA2026-08-03
excluded packagepackage52959-81252959-812-21IInactivated by FDA2026-08-03
excluded packagepackage52959-81252959-812-45IInactivated by FDA2026-08-03

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
A203068-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203068-001AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2025-01-19 17:59 UTC2025-01A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-063f01610625f2…
2019-09-15 20:21 UTC2019-09A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06cb3db0bc1861…
2026-08-01 22:54:322026-06A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-01-19 17:59 UTC2025-01A203068-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203068-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203068-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203068-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203068-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203068-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203068-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203068-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203068-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203068-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203068-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203068-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203068-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203068-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203068-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203068-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A203068-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203068-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203068-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203068-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A203068-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203068-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203068-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203068-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203068-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203068-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203068-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203068-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203068-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203068-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203068-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203068-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203068-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203068-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203068-001AA1cb3db0bc1861…
2026-08-01 22:54:322026-06A203068-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEAurolife Pharma LLC5927e0f6-3de3-4885-a633-5b92003f6fe42026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203068
application number: ANDA203068
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDIRECT RXc3dda0a4-b428-f3e7-e053-2995a90ad1062025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203068
application number: ANDA203068
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LPb3c48b3c-fab7-4ea4-93b0-b108979e9da32022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203068
application number: ANDA203068

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, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-812-212020-01-31C16284748780-19d75b9d0-4312-f424-e053-dadaa90a57ce5486d426-4704-0bed-e054-00144ff8d46c
52959-812-452020-01-31C16284748780-19d75b9d0-4312-f424-e053-dadaa90a57ce5486d426-4704-0bed-e054-00144ff8d46c
52959-812-072019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
52959-812-102019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
52959-812-112019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
52959-812-142019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
52959-812-202019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
52959-812-222019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
52959-812-282019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
52959-812-302019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
52959-812-602019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
52959-812-902019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-812-07Phentermine Hydrochloride7 in 1 BOTTLETABLET72
52959-812-10Phentermine Hydrochloride10 in 1 BOTTLETABLET102
52959-812-11Phentermine Hydrochloride11 in 1 BOTTLETABLET112
52959-812-14Phentermine Hydrochloride14 in 1 BOTTLETABLET142
52959-812-20Phentermine Hydrochloride20 in 1 BOTTLETABLET202
52959-812-21Phentermine Hydrochloride21 in 1 BOTTLETABLET212
52959-812-22Phentermine Hydrochloride22 in 1 BOTTLETABLET222
52959-812-28Phentermine Hydrochloride28 in 1 BOTTLETABLET282
52959-812-30Phentermine Hydrochloride30 in 1 BOTTLETABLET302
52959-812-45Phentermine Hydrochloride45 in 1 CONTAINERTABLET452
52959-812-60Phentermine Hydrochloride60 in 1 BOTTLETABLET602
52959-812-90Phentermine Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-812-07EA - Each52959-812100113a3-fcfb-4f27-b704-5d15323757e712012-07-24
52959-812-10EA - Each52959-812f8d66d7e-77a1-4806-bc7f-5c4cd1bb161b12012-07-24
52959-812-11EA - Each52959-812adde597c-c9a7-4739-b969-36e2862cc69412012-07-24
52959-812-14EA - Each52959-812ec7e123b-e78b-4269-8f7d-203520f3483812012-07-24
52959-812-20EA - Each52959-812f0cbdd02-2245-4c74-a59e-221158df535512012-07-24
52959-812-22EA - Each52959-81265eb80fa-60e5-428f-806a-1632223654eb12012-07-24
52959-812-30EA - Each52959-812b76a984e-d02a-4c5c-97d1-fda566361cfe12012-07-24
52959-812-60EA - Each52959-81298fbdcb9-6fa9-432b-ba11-add088b14b6012012-07-24
52959-812-90EA - Each52959-81282da4eb5-04d2-4b06-81f7-db0f6475139112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phentermine HydrochlorideACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
PhentermineACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-812PHENTERMINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 2 package rows20180103_5486d426-4704-0bed-e054-00144ff8d46c.zip
52959-812PHENTERMINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 10 package rows20111230_a894c87a-f04d-4080-a52b-b3fd8b8b6e01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN5486d426-4704-0bed-e054-00144ff8d46c2
803353phentermine HCl 37.5 MG Oral TabletPSNa894c87a-f04d-4080-a52b-b3fd8b8b6e012
803353phentermine hydrochloride 37.5 MG Oral TabletSCD5486d426-4704-0bed-e054-00144ff8d46c2
803353phentermine hydrochloride 37.5 MG Oral TabletSCDa894c87a-f04d-4080-a52b-b3fd8b8b6e012
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY5486d426-4704-0bed-e054-00144ff8d46c2
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYa894c87a-f04d-4080-a52b-b3fd8b8b6e012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-812-07529590812077 in 1 BOTTLEHistorical
52959-812-105295908121010 in 1 BOTTLEHistorical
52959-812-115295908121111 in 1 BOTTLEHistorical
52959-812-145295908121414 in 1 BOTTLEHistorical
52959-812-205295908122020 in 1 BOTTLEHistorical
52959-812-215295908122121 in 1 BOTTLEHistorical
52959-812-225295908122222 in 1 BOTTLEHistorical
52959-812-285295908122828 in 1 BOTTLEHistorical
52959-812-305295908123030 in 1 BOTTLEHistorical
52959-812-455295908124545 in 1 CONTAINERHistorical
52959-812-605295908126060 in 1 BOTTLEHistorical
52959-812-905295908129090 in 1 BOTTLEHistorical