Home NDC 63629-5075 Phentermine Hydrochloride
Product NDC 63629-5075
11-digit product format 636295075
Labeler code 63629
Product ID 63629-5075_3ab4628c-286b-45b7-b827-4eb633d5c434
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phentermine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA091359
Marketing category ANDA
Marketing start 2010-07-19
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 No
Listing certified through 2021-12-31
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 · 64 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A091359-001 PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16
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 · 43 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 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2010-07-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL AA 2010-07-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091359-001 PHENTERMINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2010-07-16 f41ea6bd6efb…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2019-09-15 20:21 UTC 2019-09 A091359-001 AA 1 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091359-001 AA 1 ea99ee380514…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-5075-1 2020-05-22 These highlights do not include all the information needed to use phentermine hydrochloride capsules, USP safely and effectively. See full prescribing information for phentermine hydrochloride capsules, USP. PHENTERMINE Hydrochloride Capsules, USP for oral use CIV Initial U.S. Approval: 1959 63629-5075-2 2020-05-22 These highlights do not include all the information needed to use phentermine hydrochloride capsules, USP safely and effectively. See full prescribing information for phentermine hydrochloride capsules, USP. PHENTERMINE Hydrochloride Capsules, USP for oral use CIV Initial U.S. Approval: 1959 63629-5075-3 2020-05-22 These highlights do not include all the information needed to use phentermine hydrochloride capsules, USP safely and effectively. See full prescribing information for phentermine hydrochloride capsules, USP. PHENTERMINE Hydrochloride Capsules, USP for oral use CIV Initial U.S. Approval: 1959 63629-5075-1 2019-11-27 These highlights do not include all the information needed to use phentermine hydrochloride capsules, USP safely and effectively. See full prescribing information for phentermine hydrochloride capsules, USP. PHENTERMINE Hydrochloride Capsules, USP for oral use CIV Initial U.S. Approval: 1959 63629-5075-2 2019-11-27 These highlights do not include all the information needed to use phentermine hydrochloride capsules, USP safely and effectively. See full prescribing information for phentermine hydrochloride capsules, USP. PHENTERMINE Hydrochloride Capsules, USP for oral use CIV Initial U.S. Approval: 1959 63629-5075-3 2019-11-27 These highlights do not include all the information needed to use phentermine hydrochloride capsules, USP safely and effectively. See full prescribing information for phentermine hydrochloride capsules, USP. PHENTERMINE Hydrochloride Capsules, USP for oral use CIV Initial U.S. Approval: 1959
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-5075-1 63629507501 30 CAPSULE in 1 BOTTLE (63629-5075-1) 30 capsule 2013-10-18 0000-00-00 No No Current 63629-5075-2 63629507502 7 CAPSULE in 1 BOTTLE (63629-5075-2) 7 capsule 2013-10-18 0000-00-00 No No Current 63629-5075-3 63629507503 14 CAPSULE in 1 BOTTLE (63629-5075-3) 14 capsule 2013-10-18 0000-00-00 No No Current 63629-5075-4 63629507504 28 CAPSULE in 1 BOTTLE (63629-5075-4) 28 capsule 2013-10-18 0000-00-00 No No Current