Home NDC 10702-001 LOMAIRA
Product NDC 10702-001
11-digit product format 107020001
Labeler code 10702
Product ID 10702-001_0ce01306-ef7f-563f-e063-6394a90a52b7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phentermine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler KVK-TECH, INC.
Application ANDA203495
Marketing category ANDA
Marketing start 2016-09-12
Substance PHENTERMINE HYDROCHLORIDE
Active strength 8 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 A203495-001 LOMAIRA PHENTERMINE HYDROCHLORIDE 8MG TABLET / ORAL AA RS 2016-09-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203495-001 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 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203495-001 LOMAIRA 8MG TABLET / ORAL AA RS 2016-09-12 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 LOMAIRA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENTERMINE HYDROCHLORIDE 8 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 826919 Internal RxNorm lookup 1810304 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10702-001 LOMAIRA (PHENTERMINE HYDROCHLORIDE) TABLET [KVK-TECH, INC.] 7 Current NDC, Legacy NDC, 6 package rows 20231220_cde9fb09-e5af-434d-8874-e4f9f974d893.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 · 2 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 10702-001-03 10702000103 30 TABLET in 1 BOTTLE (10702-001-03) 30 tablet 2016-09-12 0000-00-00 No No Current 10702-001-06 10702000106 60 TABLET in 1 BOTTLE (10702-001-06) 60 tablet 2016-09-12 0000-00-00 No No Current 10702-001-09 10702000109 90 TABLET in 1 BOTTLE (10702-001-09) 90 tablet 2016-09-12 0000-00-00 No No Current 10702-001-10 10702000110 1000 TABLET in 1 BOTTLE (10702-001-10) 1000 tablet 2016-09-12 0000-00-00 No No Current 10702-001-25 10702000125 250 TABLET in 1 BOTTLE (10702-001-25) 250 tablet 2016-09-12 0000-00-00 No No Current 10702-001-50 10702000150 500 TABLET in 1 BOTTLE (10702-001-50) 500 tablet 2016-09-12 0000-00-00 No No Current