Home NDC 40032-950-50 Oxycodone Hydrochloride
Product NDC 40032-950
Requested package NDC 40032-950-50
11-digit product format 400320950
Labeler code 40032
Product ID 40032-950_65077bf1-49cf-4205-91f6-d6e2e81281ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Novel Laboratories, Inc.
Application ANDA204752
Marketing category ANDA
Marketing start 2015-08-24
Substance OXYCODONE HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 7 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204752-001 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204752-001 AB
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 2 · 42 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 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204752-001 OXYCODONE HYDROCHLORIDE 5MG CAPSULE / ORAL AB 2015-08-24 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Oxycodone Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYCODONE HYDROCHLORIDE 5 mg/1
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049696 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 40032-950-01 Oxycodone Hydrochloride 100 in 1 BOTTLE CAPSULE 100 7 40032-950-03 Oxycodone Hydrochloride 30 in 1 BOTTLE CAPSULE 30 7 40032-950-50 Oxycodone Hydrochloride 500 in 1 BOTTLE CAPSULE 500 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXYCODONE HYDROCHLORIDE ACTIVE INGREDIENT C1ENJ2TE6C OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] 2 OXYCODONE ACTIVE MOIETY CD35PMG570 OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] 2 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 40032-950 OXYCODONE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] 7 Current NDC, Legacy NDC, 3 package rows 20231214_69410bf3-0d3a-41f9-b10a-c4ee3770f728.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 Units Marketing start Sample Exclude flag Status 40032-950-50 40032095050 500 CAPSULE in 1 BOTTLE (40032-950-50) 500 capsule 2015-08-24 No No Current