Home NDC 68788-7691-1 Phentermine
Product NDC 68788-7691
Requested package NDC 68788-7691-1
11-digit product format 687887691
Labeler code 68788
Product ID 68788-7691_bbc85a09-dee2-4ed9-bc4b-9ce59a4dd1e3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phentermine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA204318
Marketing category ANDA
Marketing start 2020-04-01
Marketing end 0000-00-00
Substance PHENTERMINE HYDROCHLORIDE
Active strength 15 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 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 6 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68788-7691 68788-7691-1 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68788-7691 68788-7691-1 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68788-7691 68788-7691-1 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68788-7691 68788-7691-1 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68788-7691 68788-7691-1 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68788-7691 68788-7691-1 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
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 A204318-001 PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 A204318-002 PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09
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 · 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 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204318-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2016-11-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204318-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2016-11-09 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Phentermine PHENTERMINE HYDROCHLORIDE Aurolife Pharma, LLC 737eef3b-9a6b-4ab3-a25c-49d84d2a0197 2019-01-04 Warnings, Adverse reactions Exact identifier application applno (ANDA): 204318 application number: ANDA204318
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68788-7691-1 68788769101 7 CAPSULE in 1 BOTTLE (68788-7691-1) 7 capsule 2020-04-01 0000-00-00 No No Current