Home NDC 50090-3282-4 Phentermine
Product NDC 50090-3282
Requested package NDC 50090-3282-4
11-digit product format 500903282
Labeler code 50090
Product ID 50090-3282_d7050da0-f45b-4b9b-a312-aa70cbfe730b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phentermine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler A-S Medication Solutions
Application ANDA204318
Marketing category ANDA
Marketing start 2017-03-20
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 2022-12-31
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 1 · 15 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 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# 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 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
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 50090-3282-0 2023-01-30 C162847 48780-1 f386c649-ee51-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP CIV safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP PHENTERMINE hydrochloride capsules, for oral use Initial U.S. Approval: 1959 50090-3282-2 2023-01-30 C162847 48780-1 f386c649-ee51-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP CIV safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP PHENTERMINE hydrochloride capsules, for oral use Initial U.S. Approval: 1959 50090-3282-4 2023-01-30 C162847 48780-1 f386c649-ee51-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP CIV safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP PHENTERMINE hydrochloride capsules, for oral use Initial U.S. Approval: 1959 50090-3282-5 2023-01-30 C162847 48780-1 f386c649-ee51-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP CIV safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP PHENTERMINE hydrochloride capsules, for oral use Initial U.S. Approval: 1959
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-3282-0 Phentermine 28 in 1 BOTTLE CAPSULE 28 16 50090-3282-2 Phentermine 14 in 1 BOTTLE, PLASTIC CAPSULE 14 16 50090-3282-4 Phentermine 30 in 1 BOTTLE CAPSULE 30 16 50090-3282-5 Phentermine 60 in 1 BOTTLE CAPSULE 60 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-3282 PHENTERMINE (PHENTERMINE HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS] 16 Legacy NDC, 4 package rows 20210818_8229adf5-b128-41a5-a3cc-16db4001801c.zip
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 50090-3282-4 50090328204 30 CAPSULE in 1 BOTTLE (50090-3282-4) 30 capsule 2018-01-03 0000-00-00 No No Current