Home NDC 42806-524 PHENTERMINE HYDROCHLORIDE
Product NDC 42806-524
11-digit product format 428060524
Labeler code 42806
Product ID 42806-524_eb0dd945-2ebd-422f-9228-7460f93d7889
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PHENTERMINE HYDROCHLORIDE
Dosage form CAPSULE
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA040228
Marketing category ANDA
Marketing start 2015-04-15
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 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 A040228-001 PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 1997-06-19
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 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 1997-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 1997-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 1997-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 1997-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 1997-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL 1997-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040228-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 1997-06-19 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 803348 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42806-524-01 PHENTERMINE HYDROCHLORIDE 100 in 1 BOTTLE CAPSULE 100 5 42806-524-10 PHENTERMINE HYDROCHLORIDE 1000 in 1 BOTTLE CAPSULE 1000 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENTERMINE HYDROCHLORIDE ACTIVE INGREDIENT 0K2I505OTV PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 2 PHENTERMINE ACTIVE MOIETY C045TQL4WP PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 2 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 2 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 2 METHYL ALCOHOL INACTIVE INGREDIENT Y4S76JWI15 PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-524 PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20191123_06573bd8-67b4-4478-8325-aa6be25787cb.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 42806-524-01 42806052401 100 CAPSULE in 1 BOTTLE (42806-524-01) 100 capsule 2015-04-15 0000-00-00 No No Current 42806-524-10 42806052410 1000 CAPSULE in 1 BOTTLE (42806-524-10) 1000 capsule 2015-04-15 0000-00-00 No No Current