Home NDC 64950-354 Oxycodone Hydrochloride
Product NDC 64950-354
11-digit product format 649500354
Labeler code 64950
Product ID 64950-354_75ee6920-096a-4dd9-ae98-6991ab84daff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Genus Lifesciences Inc.
Application NDA200535
Marketing category NDA
Marketing start 2013-09-09
Substance OXYCODONE HYDROCHLORIDE
Active strength 5 mg/5mL
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 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 N200535-001 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 N200535-002 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22
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 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N200535-001 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL AA RLD, RS 2010-10-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N200535-002 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD 2013-08-22 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Oxycodone Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYCODONE HYDROCHLORIDE 5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C1ENJ2TE6C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049604 Internal RxNorm lookup 1049615 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 64950-354-05 Oxycodone Hydrochloride 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 25 64950-354-10 Oxycodone Hydrochloride 1 in 1 CARTON SOLUTION 1 25 64950-354-10 Oxycodone Hydrochloride 100 mL in 1 BOTTLE, PLASTIC SOLUTION 100 25 64950-354-45 Oxycodone Hydrochloride 40 in 1 CASE SOLUTION 40 25 64950-354-50 Oxycodone Hydrochloride 500 mL in 1 BOTTLE, PLASTIC SOLUTION 500 25 64950-354-50 Oxycodone Hydrochloride 1 in 1 CARTON SOLUTION 1 25 64950-354-55 Oxycodone Hydrochloride 50 in 1 CASE SOLUTION 50 25
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Oxycodone Hydrochloride ACTIVE INGREDIENT C1ENJ2TE6C OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] 11 Oxycodone ACTIVE MOIETY CD35PMG570 OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] 11 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] 11 D&C Yellow no. 10 INACTIVE INGREDIENT 35SW5USQ3G OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] 11 FD&C Red no. 40 INACTIVE INGREDIENT WZB9127XOA OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] 11 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] 11 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] 11 sorbitol INACTIVE INGREDIENT 506T60A25R OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] 11 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] 11 water INACTIVE INGREDIENT 059QF0KO0R OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64950-354 OXYCODONE HYDROCHLORIDE SOLUTION [GENUS LIFESCIENCES INC.] 23 Current NDC, Legacy NDC, 7 package rows 20240927_6869fec9-1837-4221-afd8-5cc6fadd025d.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 · 2 matching rows.
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 64950-354-05 64950035405 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 64950-354-10 64950035410 1 BOTTLE, PLASTIC in 1 CARTON (64950-354-10) / 100 mL in 1 BOTTLE, PLASTIC 2013-09-09 0000-00-00 No No Current 64950-354-45 64950035445 40 CUP, UNIT-DOSE in 1 CASE (64950-354-45) / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05) 2013-09-09 0000-00-00 No No Current 64950-354-50 64950035450 1 BOTTLE, PLASTIC in 1 CARTON (64950-354-50) / 500 mL in 1 BOTTLE, PLASTIC 2013-09-09 0000-00-00 No No Current 64950-354-55 64950035455 50 CUP, UNIT-DOSE in 1 CASE (64950-354-55) / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05) 2013-09-09 0000-00-00 No No Current