PHENTERMINE HYDROCHLORIDE

Product NDC
72189-253
11-digit product format
721890253
Labeler code
72189
Product ID
72189-253_2c28de82-39db-9df3-e063-6394a90ac7f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENTERMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
DirectRx
Application
ANDA205019
Marketing category
ANDA
Marketing start
2021-08-25
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
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 4 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct72189-253UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-25372189-253-30UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct72189-253UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-25372189-253-30UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
A205019-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-05
A205019-002PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A205019-001AA
A205019-002AA

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 UTC2026-02A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-05782e0a99824c…
2021-12-28 21:50 UTC2021-12A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-05782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205019-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205019-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205019-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205019-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205019-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205019-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205019-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205019-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205019-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205019-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205019-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205019-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205019-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205019-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205019-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205019-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205019-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205019-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205019-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205019-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205019-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205019-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205019-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205019-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205019-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205019-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205019-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205019-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205019-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205019-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205019-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205019-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205019-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205019-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205019-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205019-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205019-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205019-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205019-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205019-002AA1782e0a99824c…

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.130e6087-0ab6-4456-a781-d370f363dc382026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.d24aaa53-9c78-4c1b-9495-c785a9cf2b262026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutionsc53bd3c5-01f6-4a21-9e3c-aa4969a01b4b2026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackfa5de92d-a5bf-4ae1-8e13-ad827aeebea32026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacka9270c14-499f-4c07-a1eb-c0aab5d8731f2025-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.d77f31b4-7e36-4a0a-a55b-78b4b6ab5cb72025-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.70bc6f36-8087-4ccd-a396-a911c0ebae792025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack640d71d8-45c9-42fb-ad96-2f3ac60afc9c2025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackfe78b5b4-47bf-484b-ab37-e0d7de6fad572025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e4508aa9-1e7a-4af7-829e-5fa353c92f5e2025-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDESUNRISE PHARMACEUTICAL, INC.a0439c85-5ede-4e02-aed2-47debd2c8eb22025-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacka1bca4b5-df64-4bac-a3a2-67f5c1eddbce2025-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HCL C-IVPHENTERMINE HCL C-IVDirect_Rxe4a2996e-2bfa-376f-e053-2995a90a0ed12025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDirectRxca683656-16a6-9602-e053-2a95a90aa8952025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
ndc (product): 72189-253
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackc8516abe-5ad1-4b76-8e2c-96ee455979cf2024-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackf427f067-f1a7-4d60-8ce0-90b20e2d4eb52024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackf50f5453-e06d-4e39-b868-9bdadf1d8baa2024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack3c37d637-779d-4097-85ef-e4ce7d0fb86a2024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack81751ece-8ccb-4aec-91ad-037c1d9fea532023-11-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEAsclemed USA, Inc.22683183-a828-47a4-9e52-38175d7c6f212023-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019

Additional Listing Data#

Finished product
Yes
Brand name base
PHENTERMINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE30 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
900038Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ca683656-16a6-9602-e053-2a95a90aa895Available 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
72189-253-30PHENTERMINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-253PHENTERMINE HYDROCHLORIDE CAPSULE [DIRECTRX]2Current NDC, Legacy NDC, 1 package rows20250121_ca683656-16a6-9602-e053-2a95a90aa895.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSNca683656-16a6-9602-e053-2a95a90aa8952
900038phentermine hydrochloride 30 MG Oral CapsuleSCDca683656-16a6-9602-e053-2a95a90aa8952
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYca683656-16a6-9602-e053-2a95a90aa8952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-253-307218902533030 CAPSULE in 1 BOTTLE (72189-253-30) 30 capsule2021-08-250000-00-00NoNoCurrent