Home NDC 64850-622 Oxycodone Hydrochloride and Acetaminophen
Product NDC 64850-622
11-digit product format 648500622
Labeler code 64850
Product ID 64850-622_523e66c8-fe6d-48c6-ab88-8c5eb25697b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone Hydrochloride and Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Elite Laboratories, Inc.
Application ANDA209385
Marketing category ANDA
Marketing start 2017-12-04
Substance ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength 325; 7.5 mg/1; mg/1
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209385-001 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET / ORAL AA 2018-07-02 A209385-002 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET / ORAL AA 2018-07-02 A209385-003 OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET / ORAL AA 2018-07-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
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 2026-08-01 22:54:32 2026-06 A209385-001 OXYCODONE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-07-02 a50c72e98297…2026-08-01 22:54:32 2026-06 A209385-002 OXYCODONE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-07-02 a50c72e98297…2026-08-01 22:54:32 2026-06 A209385-003 OXYCODONE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-07-02 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Oxycodone Hydrochloride and Acetaminophen OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN St. Mary's Medical Park Pharmacy 40a882d6-a4db-1ad9-e063-6394a90a7268 2026-07-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209385 application number: ANDA209385 Oxycodone Hydrochloride and Acetaminophen OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN St. Mary's Medical Park Pharmacy 40a68a27-4422-5ba0-e063-6294a90ac550 2026-06-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209385 application number: ANDA209385 Oxycodone Hydrochloride and Acetaminophen OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN St. Mary's Medical Park Pharmacy 53de17b1-6d5b-c7c0-e063-6394a90a7064 2026-06-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209385 application number: ANDA209385 Oxycodone Hydrochloride and Acetaminophen OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN Elite Laboratories, Inc. 27fa8190-d334-4bb9-b277-d1f44db433e3 2026-04-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209385 application number: ANDA209385 ndc (product): 64850-622
Additional Listing Data#
Finished product Yes
Brand name base Oxycodone Hydrochloride and Acetaminophen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYCODONE HYDROCHLORIDE 325 mg/1 ACETAMINOPHEN 7.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup C1ENJ2TE6C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049214 Internal RxNorm lookup 1049221 Internal RxNorm lookup 1049225 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64850-622-01 Oxycodone Hydrochloride and Acetaminophen 100 in 1 BOTTLE TABLET 100 16 64850-622-05 Oxycodone Hydrochloride and Acetaminophen 500 in 1 BOTTLE TABLET 500 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64850-622 OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLET [ELITE LABORATORIES, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20240829_27fa8190-d334-4bb9-b277-d1f44db433e3.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64850-622-01 64850062201 100 TABLET in 1 BOTTLE (64850-622-01) 100 tablet 2017-12-04 No No Current 64850-622-05 64850062205 500 TABLET in 1 BOTTLE (64850-622-05) 500 tablet 2026-04-09 No No Current