Home NDC 13107-061 Phentermine Hydrochloride
Product NDC 13107-061
11-digit product format 131070061
Labeler code 13107
Product ID 13107-061_0add1627-bf2b-40ba-b5a4-1cf580496a38
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phentermine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Aurolife Pharma, LLC
Application ANDA203068
Marketing category ANDA
Marketing start 2014-08-06
Substance PHENTERMINE HYDROCHLORIDE
Active strength 37.5 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 42 .
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 A203068-001 PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203068-001 AA
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 · 42 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 2026-08-18 06:07:40 2026-07 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203068-001 PHENTERMINE HYDROCHLORIDE 37.5MG TABLET / ORAL AA 2014-08-06 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base PHENTERMINE HYDROCHLORIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENTERMINE HYDROCHLORIDE 37.5 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 803353 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 13107-061-01 Phentermine Hydrochloride 100 in 1 BOTTLE TABLET 100 7 13107-061-05 Phentermine Hydrochloride 500 in 1 BOTTLE TABLET 500 7 13107-061-30 Phentermine Hydrochloride 30 in 1 BOTTLE TABLET 30 7 13107-061-99 Phentermine Hydrochloride 1000 in 1 BOTTLE TABLET 1000 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENTERMINE HYDROCHLORIDE ACTIVE INGREDIENT 0K2I505OTV PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC] 5 PHENTERMINE ACTIVE MOIETY C045TQL4WP PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC] 5 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC] 5 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC] 5 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC] 5 SUCROSE INACTIVE INGREDIENT C151H8M554 PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13107-061 PHENTERMINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC] 7 Current NDC, Legacy NDC, 4 package rows 20190110_5927e0f6-3de3-4885-a633-5b92003f6fe4.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 · 3 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 13107-061-01 13107006101 100 TABLET in 1 BOTTLE (13107-061-01) 100 tablet 2014-08-06 0000-00-00 No No Current 13107-061-05 13107006105 500 TABLET in 1 BOTTLE (13107-061-05) 500 tablet 2014-08-06 0000-00-00 No No Current 13107-061-30 13107006130 30 TABLET in 1 BOTTLE (13107-061-30) 30 tablet 2014-08-06 0000-00-00 No No Current 13107-061-99 13107006199 1000 TABLET in 1 BOTTLE (13107-061-99) 1000 tablet 2014-08-06 0000-00-00 No No Current