Home NDC 64850-810 Phentermine Hydrochloride
Product NDC 64850-810
11-digit product format 648500810
Labeler code 64850
Product ID 64850-810_f2b9f70f-b5e3-4e6e-8607-5c73afbe9677
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phentermine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Elite Laboratories, Inc.
Application ANDA040190
Marketing category ANDA
Marketing start 2014-05-01
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 A040190-001 PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040190-001 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 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040190-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 1997-05-30 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64850-810-01 Phentermine Hydrochloride 100 in 1 BOTTLE TABLET 100 4 64850-810-10 Phentermine Hydrochloride 1000 in 1 BOTTLE TABLET 1000 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENTERMINE HYDROCHLORIDE ACTIVE INGREDIENT 0K2I505OTV PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] 1 PHENTERMINE ACTIVE MOIETY C045TQL4WP PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64850-810 PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20241114_0b7ad9c0-9e1e-4a69-802b-28f44267e34d.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 · 2 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 64850-810-01 64850081001 100 TABLET in 1 BOTTLE (64850-810-01) 100 tablet 2014-05-01 0000-00-00 No No Current 64850-810-10 64850081010 1000 TABLET in 1 BOTTLE (64850-810-10) 1000 tablet 2014-05-01 0000-00-00 No No Current