Phentermine Hydrochloride

Product NDC
50436-6746
11-digit product format
504366746
Labeler code
50436
Product ID
50436-6746_b8509f5f-1cf8-464c-8c59-ecfb131bc3f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA040875
Marketing category
ANDA
Marketing start
2012-08-07
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
2020-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50436-6746IInactivated by FDA2026-08-07
excluded productproduct50436-6746IInactivated by FDA2026-08-07
excluded productproduct50436-6746IInactivated by FDA2026-08-07
excluded packagepackage50436-674650436-6746-3IInactivated by FDA2026-08-07
excluded packagepackage50436-674650436-6746-1IInactivated by FDA2026-08-07
excluded packagepackage50436-674650436-6746-2IInactivated 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 2 · 82 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 productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50436-6746-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50436-6746-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50436-6746-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-6746-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-6746-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-6746-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-6746-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-6746-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-6746-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-6746-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-6746-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-6746-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-6746-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-6746-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-6746-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-6746-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-6746-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-6746-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-6746-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-6746-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-6746-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-6746-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-6746-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-6746-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-6746-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-6746-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-6746-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-6746-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-6746-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-6746-3ad56d346431e…cc804d4bbf1e…

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
A040875-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040875-001AA

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 · 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 UTC2026-02A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-213f01610625f2…
2019-09-15 20:21 UTC2019-09A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040875-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-21cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040875-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040875-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040875-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040875-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040875-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040875-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040875-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040875-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040875-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040875-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040875-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040875-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040875-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040875-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040875-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040875-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040875-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040875-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040875-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040875-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040875-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040875-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040875-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040875-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040875-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040875-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040875-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040875-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040875-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040875-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040875-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040875-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040875-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040875-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040875-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040875-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040875-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040875-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040875-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040875-001AA1cb3db0bc1861…

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, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
50436-6746-22024-07-301030e365-4b58-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50436-6746-32024-07-301030e365-3166-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50436-6746-22024-01-301030e365-4b58-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50436-6746-32024-01-301030e365-3166-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50436-6746-12021-01-29ba0f9c33-30fc-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-6746-1Phentermine Hydrochloride28 in 1 BOTTLECAPSULE286
50436-6746-2Phentermine Hydrochloride28 in 1 BOTTLECAPSULE281
50436-6746-3Phentermine Hydrochloride21 in 1 BOTTLECAPSULE211

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-6746PHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]6Legacy NDC, 1 package rows20190531_f05537a9-1b2f-4e3a-a8b6-eb52dc22fc99.zip
50436-6746PHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES.]1Legacy NDC, 1 package rows20230928_7a8e685d-2f82-457b-ab95-e016db189c8f.zip
50436-6746PHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]1Legacy NDC, 1 package rows20230829_3be105f2-54d3-4fc3-a732-d5fda43a47cf.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.6749c074-52a1-4d74-96a2-d9302b3c49a12025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040875
application number: ANDA040875
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions5234cabd-6b3e-404d-a0cd-256ee5fcc8f12025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040875
application number: ANDA040875
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions7198d596-3e1c-49d5-91aa-c62fa2e2b8002025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040875
application number: ANDA040875
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack7f1c3a5d-dd9b-4441-a483-aa5777f8e40c2024-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040875
application number: ANDA040875
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEKVK-Tech, Inc.b963f7bb-fa65-4e28-81c9-282fbe70a6a62024-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040875
application number: ANDA040875
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.f938b0ab-606e-8b21-e053-6294a90a4f4c2023-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040875
application number: ANDA040875
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LPf2da0b5a-c7d6-48c3-98e9-7c611eb6ff7e2019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040875
application number: ANDA040875

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSNf05537a9-1b2f-4e3a-a8b6-eb52dc22fc996
900038phentermine hydrochloride 30 MG Oral CapsuleSCDf05537a9-1b2f-4e3a-a8b6-eb52dc22fc996
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYf05537a9-1b2f-4e3a-a8b6-eb52dc22fc996
900038phentermine HCl 30 MG Oral CapsulePSN3be105f2-54d3-4fc3-a732-d5fda43a47cf1
900038phentermine HCl 30 MG Oral CapsulePSN7a8e685d-2f82-457b-ab95-e016db189c8f1
900038phentermine hydrochloride 30 MG Oral CapsuleSCD3be105f2-54d3-4fc3-a732-d5fda43a47cf1
900038phentermine hydrochloride 30 MG Oral CapsuleSCD7a8e685d-2f82-457b-ab95-e016db189c8f1
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY3be105f2-54d3-4fc3-a732-d5fda43a47cf1
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY7a8e685d-2f82-457b-ab95-e016db189c8f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-6746-15043667460128 in 1 BOTTLEHistorical
50436-6746-25043667460228 in 1 BOTTLEHistorical
50436-6746-35043667460321 in 1 BOTTLEHistorical