Phentermine Hydrochloride

Product NDC
33261-361
11-digit product format
332610361
Labeler code
33261
Product ID
33261-361_5f577a31-f2d5-4439-88be-f3cac906776c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA040886
Marketing category
ANDA
Marketing start
2012-08-07
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
15 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
2018-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33261-361IInactivated by FDA2026-08-07
excluded packagepackage33261-36133261-361-07IInactivated by FDA2026-08-07
excluded packagepackage33261-36133261-361-08IInactivated by FDA2026-08-07
excluded packagepackage33261-36133261-361-14IInactivated by FDA2026-08-07
excluded packagepackage33261-36133261-361-15IInactivated by FDA2026-08-07
excluded packagepackage33261-36133261-361-23IInactivated by FDA2026-08-07
excluded packagepackage33261-36133261-361-28IInactivated by FDA2026-08-07
excluded packagepackage33261-36133261-361-30IInactivated by FDA2026-08-07
excluded packagepackage33261-36133261-361-40IInactivated by FDA2026-08-07
excluded packagepackage33261-36133261-361-45IInactivated by FDA2026-08-07
excluded packagepackage33261-36133261-361-60IInactivated 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 5 · 242 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 packagepackage33261-361-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-361-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-361-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-361-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-361-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-361-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-361-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-361-23d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-361-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-361-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-361-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-361-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-361-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-361-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-361-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-361-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-361-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-361-23f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-361-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-361-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-361-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-361-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-361-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-361-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-361-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-361-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-361-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-361-232ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-361-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-361-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-361-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-361-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-361-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-361-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-361-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-361-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-361-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-361-23a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-361-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-361-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-361-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-361-28cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-361-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-361-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-361-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-361-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-361-45cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-361-23cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-361-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-361-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-361-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-361-28cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-361-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-361-07cdf11ea48f46…ba0047e9e063…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040886-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31
A040886-002PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A040886-001AA
A040886-002AA

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040886-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040886-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040886-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040886-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040886-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040886-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040886-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040886-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040886-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040886-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040886-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040886-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040886-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040886-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040886-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040886-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040886-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040886-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040886-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040886-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040886-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040886-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040886-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040886-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040886-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040886-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040886-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040886-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040886-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040886-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040886-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040886-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040886-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040886-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040886-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040886-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040886-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040886-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040886-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040886-002AA1782e0a99824c…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-361-07Phentermine Hydrochloride7 in 1 BOTTLECAPSULE71
33261-361-08Phentermine Hydrochloride8 in 1 BOTTLECAPSULE81
33261-361-14Phentermine Hydrochloride14 in 1 BOTTLECAPSULE141
33261-361-15Phentermine Hydrochloride15 in 1 BOTTLECAPSULE151
33261-361-23Phentermine Hydrochloride23 in 1 BOTTLECAPSULE231
33261-361-28Phentermine Hydrochloride28 in 1 BOTTLECAPSULE281
33261-361-30Phentermine Hydrochloride30 in 1 BOTTLECAPSULE301
33261-361-40Phentermine Hydrochloride40 in 1 BOTTLECAPSULE401
33261-361-45Phentermine Hydrochloride45 in 1 BOTTLECAPSULE451
33261-361-60Phentermine Hydrochloride60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-361-07EA - Each33261-361ead9506c-e91b-44e8-9ebd-9984f31bdb8e12015-12-02
33261-361-14EA - Each33261-3614d6b98bb-75a9-4e41-a7da-cd0a39b4ba9912015-12-02
33261-361-28EA - Each33261-3610e1f63ed-4810-46cb-9da9-0ae407de2e5812015-12-02
33261-361-30EA - Each33261-36155ee3f93-d4bf-440c-9978-74f94ee9abb312015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-361PHENTERMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 10 package rows20121007_792831e9-ce9d-4d2d-ad98-80869c4c163f.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.2f3b738f-d66b-40c1-8e69-bcd50bce3e472026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.4000c00f-aa6c-4ea5-af0e-149dde3c74db2025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f115ad6d-cf62-40e7-89d1-6183a9b5071f2025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2abc445c-daa8-7326-e054-00144ff88e882025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions5234cabd-6b3e-404d-a0cd-256ee5fcc8f12025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.1fe86035-19ef-4944-ad81-c0167a8e7fec2025-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.1a8b3c4a-f7fe-5cc9-e063-6394a90a90dd2025-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.0b4d847a-fcda-df31-e063-6294a90a0c5e2025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack7f1c3a5d-dd9b-4441-a483-aa5777f8e40c2024-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEKVK-Tech, Inc.b963f7bb-fa65-4e28-81c9-282fbe70a6a62024-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LP3a3259ec-ded3-427f-843d-928d130de3da2020-03-01Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSN792831e9-ce9d-4d2d-ad98-80869c4c163f1
900038phentermine HCl 30 MG Oral CapsulePSN792831e9-ce9d-4d2d-ad98-80869c4c163f1
968766phentermine hydrochloride 15 MG Oral CapsuleSCD792831e9-ce9d-4d2d-ad98-80869c4c163f1
900038phentermine hydrochloride 30 MG Oral CapsuleSCD792831e9-ce9d-4d2d-ad98-80869c4c163f1
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY792831e9-ce9d-4d2d-ad98-80869c4c163f1
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY792831e9-ce9d-4d2d-ad98-80869c4c163f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-361-07332610361077 in 1 BOTTLEHistorical
33261-361-08332610361088 in 1 BOTTLEHistorical
33261-361-143326103611414 in 1 BOTTLEHistorical
33261-361-153326103611515 in 1 BOTTLEHistorical
33261-361-233326103612323 in 1 BOTTLEHistorical
33261-361-283326103612828 in 1 BOTTLEHistorical
33261-361-303326103613030 in 1 BOTTLEHistorical
33261-361-403326103614040 in 1 BOTTLEHistorical
33261-361-453326103614545 in 1 BOTTLEHistorical
33261-361-603326103616060 in 1 BOTTLEHistorical