Home NDC 57664-187 oxycodone hydrochloride
Product NDC 57664-187
11-digit product format 576640187
Labeler code 57664
Product ID 57664-187_11c23682-e42c-4e33-b67f-acdcc8be3b38
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxycodone hydrochloride
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA090659
Marketing category ANDA
Marketing start 2009-05-12
Marketing end 0000-00-00
Substance OXYCODONE HYDROCHLORIDE
Active strength 15 mg/1
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 57664-187-88 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 57664-187-88 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090659-001 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2009-04-10 A090659-002 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2009-04-10 A090659-003 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2009-04-10 A090659-004 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2012-11-06 A090659-005 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2012-11-06
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 6 · 215 observed 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 2026-09-14 22:38:34 2026-08 A090659-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2009-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090659-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2009-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090659-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2009-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090659-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2012-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090659-005 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2012-11-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090659-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2009-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090659-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2009-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090659-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2009-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090659-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2012-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090659-005 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2012-11-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090659-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2009-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090659-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2009-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090659-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2009-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090659-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2012-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090659-005 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2012-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090659-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2009-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090659-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2009-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090659-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2009-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090659-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2012-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090659-005 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2012-11-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090659-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2009-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090659-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2009-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090659-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2009-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090659-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2012-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090659-005 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2012-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090659-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2009-04-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090659-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2009-04-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090659-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2009-04-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090659-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2012-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090659-005 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2012-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090659-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2009-04-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090659-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2009-04-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090659-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2009-04-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090659-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2012-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090659-005 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2012-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090659-001 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2009-04-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090659-002 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2009-04-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090659-003 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2009-04-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090659-004 OXYCODONE HYDROCHLORIDE 20MG TABLET / ORAL 2012-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090659-005 OXYCODONE HYDROCHLORIDE 10MG TABLET / ORAL 2012-11-06 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 140 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXYCODONE HYDROCHLORIDE ACTIVE INGREDIENT C1ENJ2TE6C OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 OXYCODONE ACTIVE MOIETY CD35PMG570 OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 OXYCODONE HYDROCHLORIDE ACTIVE INGREDIENT C1ENJ2TE6C OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 2 OXYCODONE ACTIVE MOIETY CD35PMG570 OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57664-187-88 57664018788 100 TABLET in 1 BOTTLE (57664-187-88) 100 tablet 2009-05-12 0000-00-00 No No Current