FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
63629-4385
Requested package NDC
63629-4385-1
11-digit product format
636294385
Labeler code
63629
Product ID
63629-4385_07e8afaf-c273-4f13-81fe-1065ec101e71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040876
Marketing category
ANDA
Marketing start
2012-08-15
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

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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-438563629-4385-1IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-438563629-4385-1IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63629-438563629-4385-1IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
A040876-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040876-001AA

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 UTC2026-02A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-313f01610625f2…
2019-09-15 20:21 UTC2019-09A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31cb3db0bc1861…

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 UTC2026-02A040876-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040876-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040876-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040876-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040876-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040876-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040876-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040876-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040876-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040876-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040876-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040876-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040876-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040876-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040876-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040876-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040876-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040876-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040876-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040876-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040876-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040876-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040876-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040876-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040876-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040876-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040876-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040876-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040876-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040876-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040876-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040876-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040876-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040876-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040876-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040876-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040876-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040876-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040876-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040876-001AA1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE37.5 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
803353Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2bd5487d-10da-4ae0-9105-273e1a5efdcbAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-4385-12021-08-17These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-22021-08-17These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-32021-08-17These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-42021-08-17These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-52021-08-17These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-62021-08-17These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-72021-08-17These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-12019-11-27These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-22019-11-27These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-32019-11-27These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-42019-11-27These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-52019-11-27These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-62019-11-27These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-72019-11-27These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4385-1Phentermine Hydrochloride7 in 1 BOTTLETABLET71009
63629-4385-2Phentermine Hydrochloride30 in 1 BOTTLETABLET301009
63629-4385-3Phentermine Hydrochloride14 in 1 BOTTLETABLET141009
63629-4385-4Phentermine Hydrochloride60 in 1 BOTTLETABLET601009
63629-4385-5Phentermine Hydrochloride28 in 1 BOTTLETABLET281009
63629-4385-6Phentermine Hydrochloride24 in 1 BOTTLETABLET241009
63629-4385-7Phentermine Hydrochloride45 in 1 BOTTLETABLET451009
63629-4385-8Phentermine Hydrochloride90 in 1 BOTTLETABLET901009
63629-4385-9Phentermine Hydrochloride21 in 1 BOTTLETABLET211009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4385-1EA - Each63629-43858c76eecf-1284-4e3f-a24c-51ff821c186a12025-08-11
63629-4385-2EA - Each63629-438503556005-a619-47cd-aa43-179bf640338012025-08-11
63629-4385-3EA - Each63629-43855654fc89-deff-4698-a72b-2912b30a7f3512025-08-11
63629-4385-6EA - Each63629-4385f9dbcb05-57ce-4af2-b6e7-5cb0c42d8f0312025-08-11
63629-4385-8EA - Each63629-43854d897521-1ef2-4194-8518-f5e6bde0259f12025-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4385PHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1009Current NDC, Legacy NDC, 9 package rows20240821_2bd5487d-10da-4ae0-9105-273e1a5efdcb.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENorthwind Health Company, LLC5528d9f7-45ad-d323-e063-6394a90a3e092026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040876
application number: ANDA040876
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions86ec6b9d-2934-4bad-8a80-0b60e2f912f32026-01-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040876
application number: ANDA040876
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.68fcc228-5f06-4ece-94f3-59b5b33c33252025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040876
application number: ANDA040876
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.c4e9ec2e-4660-4442-93d7-c05a16e137b52025-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040876
application number: ANDA040876
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.315b8a94-b7cc-1b47-e063-6294a90a2d392025-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040876
application number: ANDA040876
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.2d7ddbc2-2afc-473e-a73b-b44ab9fcfaab2025-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040876
application number: ANDA040876
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDirectRxd27d8379-aa3c-4688-e053-2995a90a44f62025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040876
application number: ANDA040876
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack2bd5487d-10da-4ae0-9105-273e1a5efdcb2024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040876
application number: ANDA040876
ndc (package): 63629-4385-1
ndc (product): 63629-4385
ndc11 (package): 63629438501
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEKVK-TECH, Inc.3b44d104-a7d0-4366-9d42-63f784f3cb222024-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040876
application number: ANDA040876

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN2bd5487d-10da-4ae0-9105-273e1a5efdcb1009
803353phentermine hydrochloride 37.5 MG Oral TabletSCD2bd5487d-10da-4ae0-9105-273e1a5efdcb1009
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY2bd5487d-10da-4ae0-9105-273e1a5efdcb1009

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-4385-1636294385017 TABLET in 1 BOTTLE (63629-4385-1) 7 tablet2024-04-020000-00-00NoNoCurrent