Home NDC 55700-658 oxycodone and acetaminophen
Product NDC 55700-658
11-digit product format 557000658
Labeler code 55700
Product ID 55700-658_2783ad86-5a26-412d-8f9f-da2e084d8934
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxycodone and acetaminophen
Dosage form TABLET
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
Application ANDA090535
Marketing category ANDA
Marketing start 2018-07-20
Marketing end 0000-00-00
Substance OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength 5 mg/1; mg/1
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2020-12-31
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 4 · 200 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090535-001 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;2.5MG TABLET / ORAL 2013-12-26 A090535-002 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET / ORAL 2013-12-26 A090535-003 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET / ORAL 2013-12-26 A090535-004 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET / ORAL 2013-12-26
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 5 · 176 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 2026-10-15 13:18:30 2026-09 A090535-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2013-12-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090535-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2013-12-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090535-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2013-12-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090535-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2013-12-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 A090535-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2013-12-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090535-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2013-12-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090535-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2013-12-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090535-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2013-12-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090535-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2013-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090535-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2013-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090535-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2013-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090535-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2013-12-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090535-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2013-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090535-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2013-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090535-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2013-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090535-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2013-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090535-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2013-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090535-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2013-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090535-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2013-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090535-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2013-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090535-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2013-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090535-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2013-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090535-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2013-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090535-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2013-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090535-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2013-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090535-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2013-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090535-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2013-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090535-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2013-12-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090535-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2013-12-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090535-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2013-12-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090535-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2013-12-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090535-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2013-12-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090535-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2013-12-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090535-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2013-12-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090535-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2013-12-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090535-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2013-12-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090535-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2013-12-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090535-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2013-12-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090535-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2013-12-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090535-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2013-12-26 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 3 · 96 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 55700-658-01 2025-01-14 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-14 2025-01-14 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-15 2025-01-14 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-20 2025-01-14 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-21 2025-01-14 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-24 2025-01-14 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-30 2025-01-14 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-40 2025-01-14 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-56 2025-01-14 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-60 2025-01-14 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-90 2025-01-14 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-01 2021-01-29 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-14 2021-01-29 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-15 2021-01-29 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-20 2021-01-29 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-21 2021-01-29 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-24 2021-01-29 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-30 2021-01-29 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-40 2021-01-29 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-56 2021-01-29 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-60 2021-01-29 Oxycodone and Acetaminophen Tablets, USP CII 55700-658-90 2021-01-29 Oxycodone and Acetaminophen Tablets, USP CII