Home NDC 70710-1328 Oxycodone and Acetaminophen
Product NDC 70710-1328
11-digit product format 707101328
Labeler code 70710
Product ID 70710-1328_d0b7fd0e-5231-4f72-920f-e78d3a96335e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone and Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals (USA) Inc.
Application ANDA210079
Marketing category ANDA
Marketing start 2017-12-28
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 2022-12-31
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A210079-001 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;2.5MG TABLET / ORAL 2017-12-28 A210079-002 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET / ORAL 2017-12-28 A210079-003 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET / ORAL 2017-12-28 A210079-004 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET / ORAL 2017-12-28
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 5 · 172 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 A210079-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2017-12-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210079-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2017-12-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210079-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2017-12-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210079-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2017-12-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210079-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2017-12-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210079-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2017-12-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210079-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2017-12-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210079-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2017-12-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210079-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2017-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210079-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2017-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210079-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2017-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210079-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2017-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210079-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2017-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210079-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2017-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210079-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2017-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210079-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2017-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210079-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2017-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210079-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2017-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210079-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2017-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210079-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2017-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210079-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2017-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210079-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2017-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210079-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2017-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210079-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2017-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210079-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2017-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210079-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2017-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210079-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2017-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210079-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2017-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210079-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2017-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210079-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2017-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210079-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2017-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210079-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2017-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210079-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2017-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210079-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2017-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210079-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2017-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210079-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2017-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210079-001 OXYCODONE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2017-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210079-002 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2017-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210079-003 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2017-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210079-004 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2017-12-28 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 52 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70710-1328-1 Oxycodone and Acetaminophen 100 in 1 BOTTLE TABLET 100 8 70710-1328-5 Oxycodone and Acetaminophen 500 in 1 BOTTLE TABLET 500 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1328 OXYCODONE AND ACETAMINOPHEN TABLET [ZYDUS PHARMACEUTICALS (USA) INC. ] 8 Legacy NDC, 2 package rows 20210113_c50617ea-66b6-43be-b579-b9a3836b73a2.zip
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 70710-1328-1 70710132801 100 TABLET in 1 BOTTLE (70710-1328-1) 100 tablet 2017-12-28 0000-00-00 No No Current 70710-1328-5 70710132805 500 TABLET in 1 BOTTLE (70710-1328-5) 500 tablet 2017-12-28 0000-00-00 No No Current