Home NDC 55700-984-90 OXYCODONE AND ACETAMINOPHEN
Product NDC 55700-984
Requested package NDC 55700-984-90
11-digit product format 557000984
Labeler code 55700
Product ID 55700-984_75d2dedc-4b3a-41f9-8aaf-cdbfce5c4db8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxycodone hydrochloride and acetaminophen
Dosage form TABLET
Route ORAL
Labeler Quality Care Products, LLC
Application ANDA040545
Marketing category ANDA
Marketing start 2022-09-28
Marketing end 0000-00-00
Substance ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength 325 mg/1; mg/1
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2023-12-31
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 A040545-001 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET / ORAL AA 2004-06-30 A040545-002 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET / ORAL AA 2004-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55700-984 OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [QUALITY CARE PRODUCTS, LLC] 3 Legacy NDC 20241225_c33734a7-2abb-47f3-abeb-041a2c033225.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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55700-984-90 55700098490 90 TABLET in 1 BOTTLE (55700-984-90) 90 tablet 2022-09-28 0000-00-00 No No Current