Home NDC 10544-593 Phentermine Hydrochloride
Product NDC 10544-593
11-digit product format 105440593
Labeler code 10544
Product ID 10544-593_4035c0a2-7dc1-4bc3-9446-e05614d0c38b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phentermine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA087022
Marketing category ANDA
Marketing start 2010-03-04
Marketing end 0000-00-00
Substance PHENTERMINE HYDROCHLORIDE
Active strength 30 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A087022-001 PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1983-02-03 A087022-002 PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL 2012-01-20
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 3 · 82 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 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1983-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL 2012-01-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1983-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL 2012-01-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1983-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL 2012-01-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1983-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL 2012-01-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1983-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL 2012-01-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1983-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL 2012-01-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1983-02-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL 2012-01-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1983-02-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL 2012-01-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1983-02-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL 2012-01-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1983-02-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL 2012-01-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1983-02-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL 2012-01-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1983-02-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL 2012-01-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1983-02-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL 2012-01-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1983-02-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL 2012-01-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 1983-02-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2012-01-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 1983-02-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2012-01-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 1983-02-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2012-01-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 1983-02-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2012-01-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 1983-02-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2012-01-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087022-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 1983-02-03 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A087022-002 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2012-01-20 782e0a99824c…
Observed Orange Book normalized TE history# 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 10544-593-28 Phentermine Hydrochloride 28 in 1 BOTTLE CAPSULE 28 1 10544-593-30 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 CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Phentermine ACTIVE MOIETY C045TQL4WP PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Alcohol INACTIVE INGREDIENT 3K9958V90M PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Aluminum Oxide INACTIVE INGREDIENT LMI26O6933 PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 butyl alcohol INACTIVE INGREDIENT 8PJ61P6TS3 PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 D&C Red NO. 28 INACTIVE INGREDIENT 767IP0Y5NH PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 D&C Yellow NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 FD&C Blue NO. 1 INACTIVE INGREDIENT H3R47K3TBD PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 FD&C Blue NO. 2 INACTIVE INGREDIENT L06K8R7DQK PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 FD&C Red NO. 40 INACTIVE INGREDIENT WZB9127XOA PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Ferrosoferric Oxide INACTIVE INGREDIENT XM0M87F357 PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Gelatin INACTIVE INGREDIENT 2G86QN327L PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Magnesium stearate INACTIVE INGREDIENT 70097M6I30 PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Methyl Alcohol INACTIVE INGREDIENT Y4S76JWI15 PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 shellac INACTIVE INGREDIENT 46N107B71O PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ 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 10544-593 PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Legacy NDC, 2 package rows 20100824_56f0bb46-57d5-4556-a00c-4f6820e4e6ce.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10544-593-28 10544059328 28 in 1 BOTTLE Historical 10544-593-30 10544059330 30 in 1 BOTTLE Historical