Home NDC 43547-404 Phentermine Hydrochloride
Product NDC 43547-404
11-digit product format 435470404
Labeler code 43547
Product ID 43547-404_e7560e52-6bb6-4f57-be5b-5132bb9f5471
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phentermine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Solco Healthcare U.S., LLC
Application ANDA040377
Marketing category ANDA
Marketing start 2002-01-04
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 A040377-001 PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040377-001 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 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040377-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2002-01-04 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 43547-404-03 2020-03-09 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 CIV for oral use Initial U.S. Approval: 1959 43547-404-10 2020-03-09 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 CIV for oral use Initial U.S. Approval: 1959 43547-404-11 2020-03-09 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 CIV for oral use Initial U.S. Approval: 1959 43547-404-03 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 CIV for oral use Initial U.S. Approval: 1959 43547-404-10 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 CIV for oral use Initial U.S. Approval: 1959 43547-404-11 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 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 43547-404-03 Phentermine Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET 30 6 43547-404-10 Phentermine Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET 100 6 43547-404-11 Phentermine Hydrochloride 1000 in 1 BOTTLE, PLASTIC TABLET 1000 6 43547-404-50 Phentermine Hydrochloride 500 in 1 BOTTLE, PLASTIC TABLET 500 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-404 PHENTERMINE HYDROCHLORIDE TABLET [SOLCO HEALTHCARE U.S., LLC] 6 Current NDC, Legacy NDC, 4 package rows 20250428_e4024b8a-25cb-4681-9bb4-44a38c74fe4b.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 43547-404-03 43547040403 30 TABLET in 1 BOTTLE, PLASTIC (43547-404-03) 30 tablet 2002-01-04 0000-00-00 No No Current 43547-404-10 43547040410 100 TABLET in 1 BOTTLE, PLASTIC (43547-404-10) 100 tablet 2002-01-04 0000-00-00 No No Current 43547-404-11 43547040411 1000 TABLET in 1 BOTTLE, PLASTIC (43547-404-11) 1000 tablet 2017-01-04 0000-00-00 No No Current 43547-404-50 43547040450 500 TABLET in 1 BOTTLE, PLASTIC (43547-404-50) 500 tablet 2025-04-21 No No Current