Phentermine Hydrochloride

Product NDC
62135-959
11-digit product format
621350959
Labeler code
62135
Product ID
62135-959_3cbb33bd-89d0-952d-e063-6294a90a4d79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA083923
Marketing category
ANDA
Marketing start
1976-07-01
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
8 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

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
A083923-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982

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 UTC2026-02A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A083923-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALApproved before 1982cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE8 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
826919Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d70f0be3-fcc7-4a1d-9a82-bb1bb21a1528Available 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
62135-959-90Phentermine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-959-90EA - Each62135-959c4221374-fd4a-4b91-81b4-6eccbcb2e38412025-09-12

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEChartwell RX, LLCd70f0be3-fcc7-4a1d-9a82-bb1bb21a15282025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083923
application number: ANDA083923
ndc (product): 62135-959

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
826919phentermine HCl 8 MG Oral TabletPSNd70f0be3-fcc7-4a1d-9a82-bb1bb21a15281
826919phentermine hydrochloride 8 MG Oral TabletSCDd70f0be3-fcc7-4a1d-9a82-bb1bb21a15281
826919phentermine HCl 8 MG (equivalent to phentermine 6.4 MG) Oral TabletSYd70f0be3-fcc7-4a1d-9a82-bb1bb21a15281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-959-906213509599090 TABLET in 1 BOTTLE (62135-959-90) 90 tablet2025-07-24NoNoCurrent