Phentermine Hydrochloride

Product NDC
10544-592
11-digit product format
105440592
Labeler code
10544
Product ID
10544-592_cd3179bd-28a3-4fb0-ba34-d8c8ba3b7267
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA040887
Marketing category
ANDA
Marketing start
2010-03-04
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
38 mg/1
Pharmacologic classes
Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10544-592IInactivated by FDA2026-08-07
excluded packagepackage10544-59210544-592-28IInactivated by FDA2026-08-07
excluded packagepackage10544-59210544-592-30IInactivated by FDA2026-08-07

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10544-592-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10544-592-28d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10544-592-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10544-592-28f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10544-592-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10544-592-282ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10544-592-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10544-592-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10544-592-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10544-592-28cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10544-592-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10544-592-28cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10544-592-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10544-592-28302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10544-592-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10544-592-28ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10544-592-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10544-592-280efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10544-592-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10544-592-28ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10544-592-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10544-592-28367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10544-592-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10544-592-28557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10544-592-308af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10544-592-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10544-592-30834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10544-592-28834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10544-592-301332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10544-592-281332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10544-592-30fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10544-592-28fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10544-592-3086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10544-592-2886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10544-592-30bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10544-592-28bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage10544-592-308dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage10544-592-288dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage10544-592-30e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage10544-592-28e2bbac7714bc…27bdfed8d636…

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
A040887-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040887-001AA

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 UTC2026-02A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-243f01610625f2…
2019-09-15 20:21 UTC2019-09A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24cb3db0bc1861…

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 UTC2026-02A040887-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040887-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040887-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040887-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040887-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040887-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040887-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040887-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040887-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040887-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040887-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040887-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040887-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040887-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040887-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040887-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040887-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040887-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040887-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040887-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040887-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040887-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040887-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040887-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040887-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040887-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040887-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040887-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040887-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040887-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040887-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040887-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040887-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040887-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040887-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040887-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040887-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040887-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040887-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040887-001AA1cb3db0bc1861…

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-592-282019-11-27C16284748780-19855d018-dea7-cd31-e053-dbdaa90ab51aUnknown Title
10544-592-302019-11-27C16284748780-19855d018-dea7-cd31-e053-dbdaa90ab51aUnknown Title

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-592-28Phentermine Hydrochloride28 in 1 BOTTLECAPSULE281
10544-592-30Phentermine Hydrochloride30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-592-28EA - Each10544-5925c3e0494-c9fe-4510-b776-094242c2e73012015-10-02
10544-592-30EA - Each10544-5922a0cb9a8-a677-491a-b169-34cc10ab04ac12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-592PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 2 package rows20130525_85e25827-c2bc-46d7-bc30-edf60f8258a3.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhenterminePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.27e88ebe-6247-4598-8ef2-c882992ed5792026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040887
application number: ANDA040887
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutionsea798229-fc2d-417c-9bc9-a3b942f0b64b2026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040887
application number: ANDA040887
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.378d863a-6977-4543-ae50-c3684a6abd9b2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040887
application number: ANDA040887
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEKVK-TECH, Inc.3b44d104-a7d0-4366-9d42-63f784f3cb222024-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040887
application number: ANDA040887

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803348phentermine HCl 37.5 MG Oral CapsulePSN85e25827-c2bc-46d7-bc30-edf60f8258a31
803353phentermine HCl 37.5 MG Oral TabletPSN85e25827-c2bc-46d7-bc30-edf60f8258a31
803348phentermine hydrochloride 37.5 MG Oral CapsuleSCD85e25827-c2bc-46d7-bc30-edf60f8258a31
803353phentermine hydrochloride 37.5 MG Oral TabletSCD85e25827-c2bc-46d7-bc30-edf60f8258a31
803348phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral CapsuleSY85e25827-c2bc-46d7-bc30-edf60f8258a31
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY85e25827-c2bc-46d7-bc30-edf60f8258a31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-592-281054405922828 in 1 BOTTLEHistorical
10544-592-301054405923030 in 1 BOTTLEHistorical