Home NDC 10544-005 Oxycodone Hydrochloride
Product NDC 10544-005
11-digit product format 105440005
Labeler code 10544
Product ID 10544-005_26de9cce-3b1f-4a5f-b2b7-0ac5584d793a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA076636
Marketing category ANDA
Marketing start 2010-06-16
Marketing end 0000-00-00
Substance OXYCODONE HYDROCHLORIDE
Active strength 30 mg/1
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag E
Listing certified through 2017-12-31
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 3 · 132 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A076636-001 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2004-02-06 A076636-002 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2004-02-06 A076636-003 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-04-07
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 4 · 129 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 2026-09-14 22:38:34 2026-08 A076636-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2004-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076636-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2004-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076636-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-04-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076636-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2004-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076636-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2004-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076636-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-04-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076636-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2004-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076636-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2004-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076636-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-04-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076636-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2004-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076636-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2004-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076636-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-04-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076636-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2004-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076636-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2004-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076636-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076636-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2004-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076636-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2004-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076636-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076636-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2004-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076636-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2004-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076636-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076636-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2004-02-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076636-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2004-02-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076636-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076636-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2004-02-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076636-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2004-02-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076636-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076636-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2004-02-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076636-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2004-02-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076636-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076636-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2004-02-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076636-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2004-02-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076636-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-04-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076636-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2004-02-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076636-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2004-02-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076636-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-04-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076636-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2004-02-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076636-002 OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL 2004-02-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076636-003 OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-04-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076636-001 OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL 2004-02-06 301d65b070ca…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 10544-005-02 Oxycodone Hydrochloride 120 in 1 BOTTLE TABLET 120 1 10544-005-30 Oxycodone Hydrochloride 30 in 1 BOTTLE TABLET 30 1 10544-005-55 Oxycodone Hydrochloride 150 in 1 BOTTLE TABLET 150 1 10544-005-60 Oxycodone Hydrochloride 60 in 1 BOTTLE TABLET 60 1 10544-005-90 Oxycodone Hydrochloride 90 in 1 BOTTLE TABLET 90 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXYCODONE HYDROCHLORIDE ACTIVE INGREDIENT C1ENJ2TE6C OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 OXYCODONE ACTIVE MOIETY CD35PMG570 OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-005 OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 Legacy NDC, 5 package rows 20100913_6fa888fc-a9d5-47f3-b28f-660d169875ae.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10544-005-02 10544000502 120 in 1 BOTTLE Historical 10544-005-30 10544000530 30 in 1 BOTTLE Historical 10544-005-55 10544000555 150 in 1 BOTTLE Historical 10544-005-60 10544000560 60 in 1 BOTTLE Historical 10544-005-90 10544000590 90 in 1 BOTTLE Historical