Home NDC 66336-147 OXYCODONE AND ACETAMINOPHEN
Product NDC 66336-147
11-digit product format 663360147
Labeler code 66336
Product ID 66336-147_9c4d3166-fb57-445e-b13e-1d19a0a5b0cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxycodone hydrochloride and acetaminophen
Dosage form TABLET
Route ORAL
Labeler Dispensing Solutions, Inc.
Application ANDA040545
Marketing category ANDA
Marketing start 2011-03-08
Marketing end 0000-00-00
Substance OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength 10 mg/1; mg/1
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag E
Listing certified through 2017-12-31
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 3 · 154 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 84 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 2026-08-18 06:07:40 2026-07 A040545-001 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2004-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040545-002 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2004-06-30 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 66336-147-24 OXYCODONE AND ACETAMINOPHEN TABLETS USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only 66336-147-30 OXYCODONE AND ACETAMINOPHEN TABLETS USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only 66336-147-55 OXYCODONE AND ACETAMINOPHEN TABLETS USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only 66336-147-60 OXYCODONE AND ACETAMINOPHEN TABLETS USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only 66336-147-90 OXYCODONE AND ACETAMINOPHEN TABLETS USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only 66336-147-94 OXYCODONE AND ACETAMINOPHEN TABLETS USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66336-147-24 OXYCODONE AND ACETAMINOPHEN 24 in 1 BOTTLE TABLET 24 1 66336-147-30 OXYCODONE AND ACETAMINOPHEN 30 in 1 BOTTLE TABLET 30 1 66336-147-55 OXYCODONE AND ACETAMINOPHEN 150 in 1 BOTTLE TABLET 150 1 66336-147-60 OXYCODONE AND ACETAMINOPHEN 60 in 1 BOTTLE TABLET 60 1 66336-147-90 OXYCODONE AND ACETAMINOPHEN 90 in 1 BOTTLE TABLET 90 1 66336-147-94 OXYCODONE AND ACETAMINOPHEN 120 in 1 BOTTLE TABLET 120 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.] 1 OXYCODONE HYDROCHLORIDE ACTIVE INGREDIENT C1ENJ2TE6C OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.] 1 OXYCODONE ACTIVE MOIETY CD35PMG570 OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66336-147 OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.] 1 Legacy NDC, 6 package rows 20111007_77a4aae7-a0cc-4f86-b91f-ec4112c6d3be.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 66336-147-24 66336014724 24 in 1 BOTTLE Historical 66336-147-30 66336014730 30 in 1 BOTTLE Historical 66336-147-55 66336014755 150 in 1 BOTTLE Historical 66336-147-60 66336014760 60 in 1 BOTTLE Historical 66336-147-90 66336014790 90 in 1 BOTTLE Historical 66336-147-94 66336014794 120 in 1 BOTTLE Historical