Home NDC 52605-022-01 Phentermine hydrochloride
Product NDC 52605-022
Requested package NDC 52605-022-01
11-digit product format 526050022
Labeler code 52605
Product ID 52605-022_995d657e-4998-40cd-8a58-a6574fb91ba9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phentermine hydrochloride
Dosage form TABLET
Route ORAL
Labeler POLYGEN PHARMACEUTICALS INC.
Application ANDA206342
Marketing category ANDA
Marketing start 2016-11-18
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 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A206342-001 PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206342-001 AA
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 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206342-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2016-11-18 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Phentermine hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENTERMINE HYDROCHLORIDE 37.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0K2I505OTV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 803353 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 52605-022-01 2025-12-09 These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets, USP. PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959 52605-022-10 2025-12-09 These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets, USP. PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959 52605-022-01 2022-01-28 These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets, USP. PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959 52605-022-10 2022-01-28 These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets, USP. PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959 52605-022-01 2020-10-22 These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets, USP. PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959 52605-022-10 2020-10-22 These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets, USP. PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959 52605-022-01 2020-01-31 These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets, USP. PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959 52605-022-10 2020-01-31 These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets, USP. PHENTERMINE hydrochloride tablets 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 52605-022-01 Phentermine hydrochloride 100 in 1 BOTTLE TABLET 100 6 52605-022-10 Phentermine hydrochloride 1000 in 1 BOTTLE TABLET 1000 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52605-022 PHENTERMINE HYDROCHLORIDE TABLET [POLYGEN PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 2 package rows 20201022_e47dc31f-9548-403e-940f-a5380f938aed.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 · 1 matching rows.
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 52605-022-01 52605002201 100 TABLET in 1 BOTTLE (52605-022-01) 100 tablet 2016-11-18 0000-00-00 No No Current