Phentermine Resin

Product NDC
0527-1398
11-digit product format
005271398
Labeler code
0527
Product ID
0527-1398_7bbef403-d696-4690-a1b1-8fd2d48eb52e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Resin
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA040872
Marketing category
ANDA
Marketing start
2011-07-28
Marketing end
0000-00-00
Substance
PHENTERMINE
Active strength
15 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
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0527-1398DDiscontinued by firm2026-08-17
excluded packagepackage0527-13980527-1398-01DDiscontinued by firm2026-08-17

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0527-1398-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0527-1398-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0527-1398-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0527-1398-01DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0527-1398-01DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0527-1398-01DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0527-1398-01DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0527-1398-01DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0527-1398-01DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0527-1398-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0527-1398-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0527-1398-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0527-1398-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0527-1398-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0527-1398-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0527-1398-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0527-1398-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0527-1398-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0527-1398-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0527-1398-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0527-1398-01IInactivated by FDA9bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040872-001PHENTERMINE RESIN COMPLEXPHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28
A040872-002PHENTERMINE RESIN COMPLEXPHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040872-001PHENTERMINE RESIN COMPLEXEQ 15MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040872-002PHENTERMINE RESIN COMPLEXEQ 30MG BASECAPSULE, EXTENDED RELEASE / ORAL2011-07-28bb7c543d1eb4…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINEACTIVE INGREDIENTC045TQL4WPPHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9
ALCOHOLINACTIVE INGREDIENT3K9958V90MPHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9
GELATININACTIVE INGREDIENT2G86QN327LPHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9
SHELLACINACTIVE INGREDIENT46N107B71OPHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9