Home NDC 68788-7972 Phentermine Hydrochloride
Product NDC 68788-7972
11-digit product format 687887972
Labeler code 68788
Product ID 68788-7972_7a6380c8-39d7-4e7b-9ee1-bb83f7b074e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name phentermine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA205019
Marketing category ANDA
Marketing start 2021-07-28
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 No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A205019-001 PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 A205019-002 PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 88 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 2026-10-15 13:18:30 2026-09 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 c2088c7a36db…2026-09-14 22:38:34 2026-08 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Phentermine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENTERMINE HYDROCHLORIDE 30 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 900038 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 68788-7972-1 Phentermine Hydrochloride 7 in 1 BOTTLE CAPSULE 7 6 68788-7972-3 Phentermine Hydrochloride 30 in 1 BOTTLE CAPSULE 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-7972 PHENTERMINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240731_d77f31b4-7e36-4a0a-a55b-78b4b6ab5cb7.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 2 of 2 · 22 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 68788-7972-1 68788797201 7 CAPSULE in 1 BOTTLE (68788-7972-1) 7 capsule 2021-07-28 0000-00-00 No No Current 68788-7972-3 68788797203 30 CAPSULE in 1 BOTTLE (68788-7972-3) 30 capsule 2021-07-28 0000-00-00 No No Current