Home NDC 10544-592 Phentermine Hydrochloride
Product NDC 10544-592
11-digit product format 105440592
Labeler code 10544
Product ID 10544-592_cd3179bd-28a3-4fb0-ba34-d8c8ba3b7267
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phentermine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA040887
Marketing category ANDA
Marketing start 2010-03-04
Marketing end 0000-00-00
Substance PHENTERMINE HYDROCHLORIDE
Active strength 38 mg/1
Pharmacologic classes Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA schedule CIV
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10544-592-28 Phentermine Hydrochloride 28 in 1 BOTTLE CAPSULE 28 1 10544-592-30 Phentermine Hydrochloride 30 in 1 BOTTLE CAPSULE 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENTERMINE HYDROCHLORIDE ACTIVE INGREDIENT 0K2I505OTV PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 PHENTERMINE ACTIVE MOIETY C045TQL4WP PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-592 PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Legacy NDC, 2 package rows 20130525_85e25827-c2bc-46d7-bc30-edf60f8258a3.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 Status 10544-592-28 10544059228 28 in 1 BOTTLE Historical 10544-592-30 10544059230 30 in 1 BOTTLE Historical