Phentermine Hydrochloride

Product NDC
10702-067
11-digit product format
107020067
Labeler code
10702
Product ID
10702-067_7d787b5e-b8c6-1ca4-e053-2991aa0a464b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
KVK-TECH, Inc.
Application
ANDA203436
Marketing category
ANDA
Marketing start
2018-03-29
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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203436-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A203436-001AA

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-173f01610625f2…
2019-09-15 20:21 UTC2019-09A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203436-001PHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAA2017-03-17cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203436-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203436-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203436-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203436-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203436-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203436-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203436-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203436-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203436-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203436-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203436-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203436-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203436-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203436-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203436-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203436-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203436-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203436-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203436-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203436-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203436-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A203436-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203436-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203436-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203436-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A203436-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203436-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203436-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203436-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203436-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203436-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203436-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203436-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203436-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203436-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203436-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203436-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203436-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203436-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203436-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0K2I505OTVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
826919Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff620c0b-aa99-4f63-9526-d094cedc8d19Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303
32c2b0bd-1f13-4890-99e0-dcd2ea16e1abProduct name220230717
ebeae3eb-385d-62da-8827-5ffa80b14e90Product name220170810
1d682039-1122-1cb7-f3f4-c0a028b98748Product name420170124
8ef9ca65-1a6c-7225-351d-36066d0f8e56Product name320161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-067-03Phentermine Hydrochloride30 in 1 BOTTLETABLET306
10702-067-05Phentermine Hydrochloride5000 in 1 BOTTLETABLET50006
10702-067-10Phentermine Hydrochloride1000 in 1 BOTTLETABLET10006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-067PHENTERMINE HYDROCHLORIDE TABLET [KVK-TECH, INC.]6Current NDC, Legacy NDC, 3 package rows20181221_ff620c0b-aa99-4f63-9526-d094cedc8d19.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEKVK-TECH, Inc.ff620c0b-aa99-4f63-9526-d094cedc8d192018-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203436
application number: ANDA203436
ndc (product): 10702-067

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
826919phentermine HCl 8 MG Oral TabletPSNff620c0b-aa99-4f63-9526-d094cedc8d196
826919phentermine hydrochloride 8 MG Oral TabletSCDff620c0b-aa99-4f63-9526-d094cedc8d196
826919phentermine HCl 8 MG (equivalent to phentermine 6.4 MG) Oral TabletSYff620c0b-aa99-4f63-9526-d094cedc8d196

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-067-031070200670330 TABLET in 1 BOTTLE (10702-067-03) 30 tablet2018-03-290000-00-00NoNoCurrent
10702-067-05107020067055000 TABLET in 1 BOTTLE (10702-067-05) 5000 tablet2018-03-290000-00-00NoNoCurrent
10702-067-10107020067101000 TABLET in 1 BOTTLE (10702-067-10) 1000 tablet2018-03-290000-00-00NoNoCurrent