Home NDC 50436-1310 Phentermine Hydrochloride
Product NDC 50436-1310
11-digit product format 504361310
Labeler code 50436
Product ID 50436-1310_18723264-f933-49a2-ae5e-cfb576ec15bb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phentermine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Unit Dose Services
Application ANDA087022
Marketing category ANDA
Marketing start 2007-12-01
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 2020-12-31
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 · 95 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# NDC, Related label table NDC Related label 50436-1310-1 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 50436-1310-2 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 50436-1310-3 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 50436-1310-4 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50436-1310-1 Phentermine Hydrochloride 7 in 1 BOTTLE CAPSULE 7 4 50436-1310-2 Phentermine Hydrochloride 14 in 1 BOTTLE CAPSULE 14 4 50436-1310-3 Phentermine Hydrochloride 21 in 1 BOTTLE CAPSULE 21 4 50436-1310-4 Phentermine Hydrochloride 28 in 1 BOTTLE CAPSULE 28 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50436-1310 PHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES] 4 Legacy NDC, 4 package rows 20170926_a56c3aa5-ca6f-4c14-ab07-fbb3f8be060c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 50436-1310-1 50436131001 7 in 1 BOTTLE Historical 50436-1310-2 50436131002 14 in 1 BOTTLE Historical 50436-1310-3 50436131003 21 in 1 BOTTLE Historical 50436-1310-4 50436131004 28 in 1 BOTTLE Historical