Home NDC 50090-3992 Phentermine Hydrochloride
Product NDC 50090-3992
11-digit product format 500903992
Labeler code 50090
Product ID 50090-3992_46d90ee5-976e-4016-a774-44eefa7665e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phentermine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler A-S Medication Solutions
Application ANDA201961
Marketing category ANDA
Marketing start 2011-07-20
Marketing end 0000-00-00
Substance PHENTERMINE HYDROCHLORIDE
Active strength 38 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 2021-12-31
Current FDA listing Historical FDA.report record 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 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201961-001 PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2011-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2011-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2011-07-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2011-07-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2011-07-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2011-07-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2011-07-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2011-07-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2011-07-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2011-07-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2011-07-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2011-07-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2011-07-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 2011-07-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2011-07-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2011-07-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2011-07-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201961-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2011-07-20 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 50090-3992-0 2023-01-30 C162847 48780-1 f386c649-c6a2-0266-e053-dadaa90a7c1a These 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 for oral use CIV Initial U.S. Approval: 1959 50090-3992-1 2023-01-30 C162847 48780-1 f386c649-c6a2-0266-e053-dadaa90a7c1a These 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 for oral use CIV Initial U.S. Approval: 1959 50090-3992-2 2023-01-30 C162847 48780-1 f386c649-c6a2-0266-e053-dadaa90a7c1a These 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 for oral use CIV Initial U.S. Approval: 1959
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-3992-0 Phentermine Hydrochloride 1000 in 1 BOTTLE CAPSULE 1000 8 50090-3992-1 Phentermine Hydrochloride 30 in 1 BOTTLE CAPSULE 30 8 50090-3992-2 Phentermine Hydrochloride 28 in 1 BOTTLE, PLASTIC CAPSULE 28 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-3992 PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS] 8 Legacy NDC, 3 package rows 20200714_6ee6b57c-bb5f-4062-8626-bf8e102ad320.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-3992-0 50090399200 1000 CAPSULE in 1 BOTTLE (50090-3992-0) 1000 capsule 2018-12-18 0000-00-00 No No Current 50090-3992-1 50090399201 30 CAPSULE in 1 BOTTLE (50090-3992-1) 30 capsule 2018-12-18 0000-00-00 No No Current 50090-3992-2 50090399202 28 CAPSULE in 1 BOTTLE, PLASTIC (50090-3992-2) 28 capsule 2014-11-28 0000-00-00 No No Current