PHENTERMINE HYDROCHLORIDE

Product NDC
21695-509
11-digit product format
216950509
Labeler code
21695
Product ID
21695-509_42a2586d-b025-4a42-83a3-747a880ed858
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENTERMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA040886
Marketing category
ANDA
Marketing start
1999-11-08
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
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 productproduct21695-509IInactivated by FDA2026-08-07
excluded packagepackage21695-50921695-509-00IInactivated by FDA2026-08-07
excluded packagepackage21695-50921695-509-30IInactivated 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 packagepackage21695-509-00d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-509-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-509-00f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-509-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-509-002ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-509-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-509-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-509-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-509-00cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-509-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-509-00cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-509-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-509-00302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-509-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-509-00ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-509-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-509-000efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-509-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-509-00ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-509-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-509-00367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-509-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-509-00557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-509-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-509-008af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-509-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-509-00834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-509-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-509-001332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-509-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-509-00fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-509-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-509-0086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-509-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-509-00bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-509-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-509-008dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-509-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-509-00e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-509-30e2bbac7714bc…27bdfed8d636…

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
21695-509-00PHENTERMINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE1001
21695-509-30PHENTERMINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-509-00EA - Each21695-50929fe637b-f335-4275-bff6-a22f715c705612012-07-24
21695-509-30EA - Each21695-5097f407215-d6dd-43fe-8728-caa2af0f40ff12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-509PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110121_42a2586d-b025-4a42-83a3-747a880ed858.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 CapsulePSN42a2586d-b025-4a42-83a3-747a880ed8581
968766phentermine hydrochloride 15 MG Oral CapsuleSCD42a2586d-b025-4a42-83a3-747a880ed8581
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY42a2586d-b025-4a42-83a3-747a880ed8581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-509-0021695050900100 in 1 BOTTLEHistorical
21695-509-302169505093030 in 1 BOTTLEHistorical