PHENTERMINE HYDROCHLORIDE

Product NDC
72189-203
11-digit product format
721890203
Labeler code
72189
Product ID
72189-203_2be977e6-4cfe-9a64-e063-6294a90a9fc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENTERMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA203068
Marketing category
ANDA
Marketing start
2021-06-03
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 · 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
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct72189-203UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-20372189-203-30UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203068-001PHENTERMINE 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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203068-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203068-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203068-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203068-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203068-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203068-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203068-001AA103ed91905a0d…
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…

Additional Listing Data#

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

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
c3dda0a4-b428-f3e7-e053-2995a90ad106Available 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
72189-203-30PHENTERMINE HYDROCHLORIDE30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-203-30EA - Each72189-203c748aae7-f10f-4a0d-a461-899b7a8bf6b512021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-203PHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]2Current NDC, Legacy NDC, 1 package rows20250119_c3dda0a4-b428-f3e7-e053-2995a90ad106.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 · 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
ndc (product): 72189-203
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LPb3c48b3c-fab7-4ea4-93b0-b108979e9da32022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203068
application number: ANDA203068

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSNc3dda0a4-b428-f3e7-e053-2995a90ad1062
803353phentermine hydrochloride 37.5 MG Oral TabletSCDc3dda0a4-b428-f3e7-e053-2995a90ad1062
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYc3dda0a4-b428-f3e7-e053-2995a90ad1062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-203-307218902033030 TABLET in 1 BOTTLE (72189-203-30) 30 tablet2021-06-030000-00-00NoNoCurrent