Home NDC 43063-182 Phentermine Hydrochloride
Product NDC 43063-182
11-digit product format 430630182
Labeler code 43063
Product ID 43063-182_41377de9-db46-c1f1-e063-6394a90a6a48
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phentermine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
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 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 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 · 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 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…2022-09-29 23:25 UTC 2022-09 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040887-001 PHENTERMINE HYDROCHLORIDE 37.5MG CAPSULE / ORAL AA 2008-04-24 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 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 43063-182-15 Phentermine Hydrochloride 15 in 1 BOTTLE, PLASTIC CAPSULE 15 15 43063-182-30 Phentermine Hydrochloride 30 in 1 BOTTLE, PLASTIC CAPSULE 30 15 43063-182-60 Phentermine Hydrochloride 60 in 1 BOTTLE, PLASTIC CAPSULE 60 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENTERMINE HYDROCHLORIDE ACTIVE INGREDIENT 0K2I505OTV PHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 PHENTERMINE ACTIVE MOIETY C045TQL4WP PHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L PHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L PHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-182 PHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 Current NDC, Legacy NDC, 3 package rows 20240507_378d863a-6977-4543-ae50-c3684a6abd9b.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 43063-182-15 43063018215 15 CAPSULE in 1 BOTTLE, PLASTIC (43063-182-15) 15 capsule 2012-08-31 0000-00-00 No No Current 43063-182-30 43063018230 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-182-30) 30 capsule 2012-08-31 0000-00-00 No No Current 43063-182-60 43063018260 60 CAPSULE in 1 BOTTLE, PLASTIC (43063-182-60) 60 capsule 2012-08-31 0000-00-00 No No Current