Home NDC 63187-800 Phentermine Hydrochloride
Product NDC 63187-800
11-digit product format 631870800
Labeler code 63187
Product ID 63187-800_4e1cdc95-3d6c-4a43-8aec-194daf2abd12
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phentermine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA203068
Marketing category ANDA
Marketing start 2011-06-10
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 A203068-001 PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203068-001 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 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 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 63187-800-07 Phentermine Hydrochloride 7 in 1 BOTTLE TABLET 7 6 63187-800-14 Phentermine Hydrochloride 14 in 1 BOTTLE TABLET 14 6 63187-800-15 Phentermine Hydrochloride 15 in 1 BOTTLE TABLET 15 6 63187-800-30 Phentermine Hydrochloride 30 in 1 BOTTLE TABLET 30 6 63187-800-60 Phentermine Hydrochloride 60 in 1 BOTTLE TABLET 60 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-800 PHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP] 6 Current NDC, Legacy NDC, 5 package rows 20220420_b3c48b3c-fab7-4ea4-93b0-b108979e9da3.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 · 3 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 63187-800-07 63187080007 7 TABLET in 1 BOTTLE (63187-800-07) 7 tablet 2017-01-02 0000-00-00 No No Current 63187-800-14 63187080014 14 TABLET in 1 BOTTLE (63187-800-14) 14 tablet 2021-06-29 0000-00-00 No No Current 63187-800-15 63187080015 15 TABLET in 1 BOTTLE (63187-800-15) 15 tablet 2017-01-02 0000-00-00 No No Current 63187-800-30 63187080030 30 TABLET in 1 BOTTLE (63187-800-30) 30 tablet 2017-01-02 0000-00-00 No No Current 63187-800-60 63187080060 60 TABLET in 1 BOTTLE (63187-800-60) 60 tablet 2017-01-02 0000-00-00 No No Current