Home NDC 68462-347 Oxycodone Hydrochloride
Product NDC 68462-347
11-digit product format 684620347
Labeler code 68462
Product ID 68462-347_8acb67cc-8aef-4685-bef9-faea52c2d167
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Glenmark Pharmaceuticals, Inc
Application NDA200535
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2010-12-20
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 2020-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68462-347-37 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68462-347-37 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68462-347-37 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68462-347-37 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68462-347-37 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68462-347-37 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68462-347-37 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68462-347-37 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68462-347-37 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68462-347-37 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68462-347-37 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68462-347-37 557ba5c1ecfa…9c80585c8c6e…
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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXYCODONE HYDROCHLORIDE ACTIVE INGREDIENT C1ENJ2TE6C OXYCODONE HYDROCHLORIDE SOLUTION, CONCENTRATE [SAFECOR HEALTH, LLC] 5 OXYCODONE ACTIVE MOIETY CD35PMG570 OXYCODONE HYDROCHLORIDE SOLUTION, CONCENTRATE [SAFECOR HEALTH, LLC] 5 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP OXYCODONE HYDROCHLORIDE SOLUTION, CONCENTRATE [SAFECOR HEALTH, LLC] 5 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G OXYCODONE HYDROCHLORIDE SOLUTION, CONCENTRATE [SAFECOR HEALTH, LLC] 5 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY OXYCODONE HYDROCHLORIDE SOLUTION, CONCENTRATE [SAFECOR HEALTH, LLC] 5 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU OXYCODONE HYDROCHLORIDE SOLUTION, CONCENTRATE [SAFECOR HEALTH, LLC] 5 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR OXYCODONE HYDROCHLORIDE SOLUTION, CONCENTRATE [SAFECOR HEALTH, LLC] 5 SORBITOL INACTIVE INGREDIENT 506T60A25R OXYCODONE HYDROCHLORIDE SOLUTION, CONCENTRATE [SAFECOR HEALTH, LLC] 5 WATER INACTIVE INGREDIENT 059QF0KO0R OXYCODONE HYDROCHLORIDE SOLUTION, CONCENTRATE [SAFECOR HEALTH, LLC] 5 Oxycodone Hydrochloride ACTIVE INGREDIENT C1ENJ2TE6C OXYCODONE HYDROCHLORIDE SOLUTION [GLENMARK GENERICS, INC] 1 Oxycodone ACTIVE MOIETY CD35PMG570 OXYCODONE HYDROCHLORIDE SOLUTION [GLENMARK GENERICS, INC] 1 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP OXYCODONE HYDROCHLORIDE SOLUTION [GLENMARK GENERICS, INC] 1 D&C Yellow NO. 10 INACTIVE INGREDIENT 35SW5USQ3G OXYCODONE HYDROCHLORIDE SOLUTION [GLENMARK GENERICS, INC] 1 Saccharin Sodium INACTIVE INGREDIENT SB8ZUX40TY OXYCODONE HYDROCHLORIDE SOLUTION [GLENMARK GENERICS, INC] 1 Sodium Benzoate INACTIVE INGREDIENT OJ245FE5EU OXYCODONE HYDROCHLORIDE SOLUTION [GLENMARK GENERICS, INC] 1 Sodium Citrate INACTIVE INGREDIENT 1Q73Q2JULR OXYCODONE HYDROCHLORIDE SOLUTION [GLENMARK GENERICS, INC] 1 Sorbitol INACTIVE INGREDIENT 506T60A25R OXYCODONE HYDROCHLORIDE SOLUTION [GLENMARK GENERICS, INC] 1 Water INACTIVE INGREDIENT 059QF0KO0R OXYCODONE HYDROCHLORIDE SOLUTION [GLENMARK GENERICS, INC] 1
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68462-347-37 68462034737 1 BOTTLE, PLASTIC in 1 CARTON (68462-347-37) > 30 mL in 1 BOTTLE, PLASTIC 2010-12-20 0000-00-00 No No Current