Home NDC 64950-353 Oxycodone Hydrochloride
Product NDC 64950-353
11-digit product format 649500353
Labeler code 64950
Product ID 64950-353_dbbd3b81-5236-48da-901c-40bcdcddbf57
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Genus Lifesciences Inc.
Application NDA200535
Marketing category NDA
Marketing start 2010-10-20
Marketing end 0000-00-00
Substance OXYCODONE HYDROCHLORIDE
Active strength 100 mg/5mL
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 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 64950-353-52 excluded package package 64950-353-51 excluded package package 64950-353-03
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# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64950-353-01 Oxycodone Hydrochloride 0.5 mL in 1 SYRINGE, PLASTIC SOLUTION 0.5 25 64950-353-02 Oxycodone Hydrochloride 1 mL in 1 SYRINGE, PLASTIC SOLUTION 1 25 64950-353-03 Oxycodone Hydrochloride 1 in 1 CARTON SOLUTION 1 25 64950-353-03 Oxycodone Hydrochloride 30 mL in 1 BOTTLE, PLASTIC SOLUTION 30 25 64950-353-51 Oxycodone Hydrochloride 50 in 1 CASE SOLUTION 50 25 64950-353-52 Oxycodone Hydrochloride 50 in 1 CASE SOLUTION 50 25 64950-353-91 Oxycodone Hydrochloride 5 in 1 POUCH SOLUTION 5 25 64950-353-92 Oxycodone Hydrochloride 5 in 1 POUCH SOLUTION 5 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 64950-353 OXYCODONE HYDROCHLORIDE SOLUTION [GENUS LIFESCIENCES INC.] 23 Legacy NDC, 8 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 64950-353-01 64950035301 0.5 mL in 1 SYRINGE, PLASTIC 0.5 ml Historical 64950-353-02 64950035302 1 mL in 1 SYRINGE, PLASTIC 1 ml Historical 64950-353-03 64950035303 1 BOTTLE, PLASTIC in 1 CARTON (64950-353-03) > 30 mL in 1 BOTTLE, PLASTIC 2010-10-20 0000-00-00 No No Current 64950-353-51 64950035351 50 POUCH in 1 CASE (64950-353-51) > 5 SYRINGE, PLASTIC in 1 POUCH (64950-353-91) > .5 mL in 1 SYRINGE, PLASTIC (64950-353-01) 50 pouch 2020-12-01 0000-00-00 No No Current 64950-353-52 64950035352 50 POUCH in 1 CASE (64950-353-52) > 5 SYRINGE, PLASTIC in 1 POUCH (64950-353-92) > 1 mL in 1 SYRINGE, PLASTIC (64950-353-02) 50 pouch 2020-12-01 0000-00-00 No No Current 64950-353-91 64950035391 5 in 1 POUCH Historical 64950-353-92 64950035392 5 in 1 POUCH Historical