Home NDC 50090-0653-0 Phentermine Hydrochloride
Product NDC 50090-0653
Requested package NDC 50090-0653-0
11-digit product format 500900653
Labeler code 50090
Product ID 50090-0653_de2d050e-ec9e-4b7a-8716-f59cf8464507
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phentermine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler A-S Medication Solutions
Application ANDA040887
Marketing category ANDA
Marketing start 2012-08-15
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A040887-001 PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040887-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Phentermine Hydrochloride
Listing expiration 2027-12-31 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 50090-0653-0 2023-02-07 These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959 50090-0653-1 2023-02-07 These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959 50090-0653-2 2023-02-07 These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959 50090-0653-0 2023-01-30 These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959 50090-0653-1 2023-01-30 These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959 50090-0653-2 2023-01-30 These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-0653-0 Phentermine Hydrochloride 1000 in 1 BOTTLE CAPSULE 1000 29 50090-0653-1 Phentermine Hydrochloride 30 in 1 BOTTLE CAPSULE 30 29 50090-0653-2 Phentermine Hydrochloride 28 in 1 BOTTLE CAPSULE 28 29
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-0653 PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS] 27 Current NDC, Legacy NDC, 3 package rows 20240215_ea798229-fc2d-417c-9bc9-a3b942f0b64b.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 · 4 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 50090-0653-0 50090065300 1000 CAPSULE in 1 BOTTLE (50090-0653-0) 1000 capsule 2019-10-09 0000-00-00 No No Current