Home NDC 13107-105 Phentermine
Product NDC 13107-105
11-digit product format 131070105
Labeler code 13107
Product ID 13107-105_53dd7857-41fb-4da1-88f7-5c68a509bfb0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phentermine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Aurolife Pharma, LLC
Application ANDA204318
Marketing category ANDA
Marketing start 2017-03-20
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Phentermine
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 900038 Internal RxNorm lookup 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 13107-105-01 Phentermine 100 in 1 BOTTLE CAPSULE 100 4 13107-105-30 Phentermine 30 in 1 BOTTLE CAPSULE 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13107-105 PHENTERMINE (PHENTERMINE HYDROCHLORIDE) CAPSULE [AUROLIFE PHARMA, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20190108_737eef3b-9a6b-4ab3-a25c-49d84d2a0197.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 1 of 1 · 1 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 13107-105-01 13107010501 100 CAPSULE in 1 BOTTLE (13107-105-01) 100 capsule 2017-03-20 0000-00-00 No No Current 13107-105-30 13107010530 30 CAPSULE in 1 BOTTLE (13107-105-30) 30 capsule 2017-03-20 0000-00-00 No No Current