Home NDC 63629-8528 Phentermine Hydrochloride
Product NDC 63629-8528
11-digit product format 636298528
Labeler code 63629
Product ID 63629-8528_35c91e1c-2b9d-4e6c-9395-63d73d77ce47
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name phentermine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA205019
Marketing category ANDA
Marketing start 2017-01-24
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 86 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 2026-09-14 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…2019-12-13 00:20 UTC 2019-12 A205019-001 PHENTERMINE HYDROCHLORIDE 15MG CAPSULE / ORAL AA 2014-12-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205019-002 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2014-12-05 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENTERMINE HYDROCHLORIDE 15 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 968766 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 63629-8528-1 Phentermine Hydrochloride 1000 in 1 BOTTLE CAPSULE 1000 103
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8528 PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 1 package rows 20240113_640d71d8-45c9-42fb-ad96-2f3ac60afc9c.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 63629-8528-1 63629852801 1000 CAPSULE in 1 BOTTLE (63629-8528-1) 1000 capsule 2021-05-19 0000-00-00 No No Current