Phentermine Hydrochloride

Product NDC
50436-0202
11-digit product format
504360202
Labeler code
50436
Product ID
50436-0202_912747da-dcd4-4a8a-9eed-2e53b0fc62ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
UNIT DOSE SERVICES
Application
ANDA202248
Marketing category
ANDA
Marketing start
2012-02-17
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50436-0202IInactivated by FDA2026-08-07
excluded packagepackage50436-020250436-0202-1IInactivated by FDA2026-08-07

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50436-0202-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-0202-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-0202-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-0202-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-0202-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-0202-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-0202-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-0202-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-0202-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-0202-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-0202-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-0202-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50436-0202-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50436-0202-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50436-0202-11332a3947898…d4bfe170f9cd…

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
A202248-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28
A202248-002PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202248-001AA
A202248-002AA

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 UTC2026-02A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28782e0a99824c…

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 UTC2026-02A202248-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202248-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202248-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202248-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202248-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202248-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202248-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202248-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202248-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202248-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202248-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202248-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202248-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202248-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202248-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202248-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202248-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202248-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202248-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202248-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202248-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202248-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202248-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202248-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202248-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202248-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202248-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202248-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202248-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202248-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202248-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202248-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202248-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202248-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202248-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202248-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202248-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202248-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202248-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202248-002AA1782e0a99824c…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0202-1Phentermine Hydrochloride21 in 1 BOTTLECAPSULE211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0202PHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]1Legacy NDC, 1 package rows20210518_5bf43fbc-7080-463c-b011-a850ed942194.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackd95e14f7-a46d-47fa-8dab-ee3d8d4c7b6d2026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b425840f-380e-42bd-852a-6ee3641977ce2026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacke48feec6-50c9-4ccd-b9da-56956d14c8532026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.1149f69d-65df-6a98-e063-6394a90aeaa42026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackd76940d3-95e6-442d-99ef-4fe92de7a3762025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPrecision Dose Inc.095a2be5-721e-46e6-976f-9137c855cd222025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack723c37c4-868f-40f0-b74d-137dcbb93f9f2025-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions8c7c1391-bfd1-48f9-b249-9729fe648b892023-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN5bf43fbc-7080-463c-b011-a850ed9421941
900038phentermine hydrochloride 30 MG Oral CapsuleSCD5bf43fbc-7080-463c-b011-a850ed9421941
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY5bf43fbc-7080-463c-b011-a850ed9421941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-0202-15043602020121 CAPSULE in 1 BOTTLE (50436-0202-1) 21 capsule2021-05-170000-00-00NoNoCurrent