Home NDC 0527-1366 Phentermine Resin
Product NDC 0527-1366
11-digit product format 005271366
Labeler code 0527
Product ID 0527-1366_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 30 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040872-001 PHENTERMINE RESIN COMPLEX PHENTERMINE RESIN COMPLEX EQ 15MG BASE CAPSULE, EXTENDED RELEASE / ORAL 2011-07-28 A040872-002 PHENTERMINE RESIN COMPLEX PHENTERMINE RESIN COMPLEX EQ 30MG BASE CAPSULE, EXTENDED RELEASE / ORAL 2011-07-28
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.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A040872-001 PHENTERMINE RESIN COMPLEX EQ 15MG BASE CAPSULE, EXTENDED RELEASE / ORAL 2011-07-28 a50c72e98297…2026-08-01 22:54:32 2026-06 A040872-002 PHENTERMINE RESIN COMPLEX EQ 30MG BASE CAPSULE, EXTENDED RELEASE / ORAL 2011-07-28 a50c72e98297…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENTERMINE ACTIVE INGREDIENT C045TQL4WP PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9 PHENTERMINE ACTIVE MOIETY C045TQL4WP PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9 GELATIN INACTIVE INGREDIENT 2G86QN327L PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9 METHYL ALCOHOL INACTIVE INGREDIENT Y4S76JWI15 PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9 SHELLAC INACTIVE INGREDIENT 46N107B71O PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9 TALC INACTIVE INGREDIENT 7SEV7J4R1U PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PHENTERMINE RESIN ER (PHENTERMINE RESIN) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 9