Oxycodone Hydrochloride

Product NDC
42806-009
11-digit product format
428060009
Labeler code
42806
Product ID
42806-009_5759388a-06ad-4a70-bd43-9c4abf69bc88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA202662
Marketing category
ANDA
Marketing start
2015-09-22
Substance
OXYCODONE HYDROCHLORIDE
Active strength
20 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202662-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-22
A202662-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-22
A202662-003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-22
A202662-004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-22
A202662-005OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2017-04-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A202662-001AB
A202662-002AB
A202662-003AB
A202662-004AB
A202662-005AB

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 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202662-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-22caaa826d4ba7…
2026-08-18 06:07:402026-07A202662-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-22caaa826d4ba7…
2026-08-18 06:07:402026-07A202662-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-22caaa826d4ba7…
2026-08-18 06:07:402026-07A202662-004OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-22caaa826d4ba7…
2026-08-18 06:07:402026-07A202662-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2017-04-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202662-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202662-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202662-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202662-004OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202662-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2017-04-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202662-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202662-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202662-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202662-004OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202662-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2017-04-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202662-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202662-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202662-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202662-004OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202662-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2017-04-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202662-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202662-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202662-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202662-004OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202662-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2017-04-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202662-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202662-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202662-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202662-004OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202662-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2017-04-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202662-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202662-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202662-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202662-004OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202662-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2017-04-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202662-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202662-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202662-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202662-004OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202662-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2017-04-272680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202662-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202662-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202662-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202662-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202662-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202662-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202662-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202662-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202662-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202662-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202662-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202662-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202662-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202662-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202662-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202662-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202662-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202662-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202662-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202662-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202662-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202662-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202662-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202662-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202662-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202662-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202662-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202662-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202662-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202662-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202662-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202662-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202662-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202662-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202662-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202662-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202662-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202662-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202662-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202662-005AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Oxycodone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C1ENJ2TE6CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049611Internal RxNorm lookup
1049618Internal RxNorm lookup
1049621Internal RxNorm lookup
1049683Internal RxNorm lookup
1049686Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cff1eee3-7c02-4f6c-acc5-1f6dcbab92c0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
b8cd3792-f010-440e-ac63-7713119fde04Product name920220110
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3Product name920190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
b7a189a6-82e9-f884-a16b-8cdc7e7d1556Product name620170913
5da64f4c-1e90-423d-af7a-5a52bb3e823eProduct name420170726
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6Product name120170628
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778Product name120161103
68d3ff71-7803-4cf4-ba84-71ce4712df22Product name120160620
07e5b999-fda7-79c9-8f77-8380537ade79Product name420160517
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7fa873c5-fb27-7119-0a05-634ad477dea7Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
f46484d2-0de6-24f4-bf73-a8f2af6723efProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-009-01Oxycodone Hydrochloride100 in 1 BOTTLETABLET10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-009-01EA - Each42806-009bba995d2-5ba2-4b8b-88e3-8b24efbdcd5912017-09-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]3
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYCODONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXYCODONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OXYCODONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-009OXYCODONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]17Current NDC, Legacy NDC, 1 package rows20221230_cff1eee3-7c02-4f6c-acc5-1f6dcbab92c0.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEEpic Pharma, LLCcff1eee3-7c02-4f6c-acc5-1f6dcbab92c02022-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202662
application number: ANDA202662
ndc (product): 42806-009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049683oxyCODONE HCl 10 MG Oral TabletPSNcff1eee3-7c02-4f6c-acc5-1f6dcbab92c017
1049611oxyCODONE HCl 15 MG Oral TabletPSNcff1eee3-7c02-4f6c-acc5-1f6dcbab92c017
1049686oxyCODONE HCl 20 MG Oral TabletPSNcff1eee3-7c02-4f6c-acc5-1f6dcbab92c017
1049618oxyCODONE HCl 30 MG Oral TabletPSNcff1eee3-7c02-4f6c-acc5-1f6dcbab92c017
1049621oxyCODONE HCl 5 MG Oral TabletPSNcff1eee3-7c02-4f6c-acc5-1f6dcbab92c017
1049683oxycodone hydrochloride 10 MG Oral TabletSCDcff1eee3-7c02-4f6c-acc5-1f6dcbab92c017
1049611oxycodone hydrochloride 15 MG Oral TabletSCDcff1eee3-7c02-4f6c-acc5-1f6dcbab92c017
1049686oxycodone hydrochloride 20 MG Oral TabletSCDcff1eee3-7c02-4f6c-acc5-1f6dcbab92c017
1049618oxycodone hydrochloride 30 MG Oral TabletSCDcff1eee3-7c02-4f6c-acc5-1f6dcbab92c017
1049621oxycodone hydrochloride 5 MG Oral TabletSCDcff1eee3-7c02-4f6c-acc5-1f6dcbab92c017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-009-0142806000901100 TABLET in 1 BOTTLE (42806-009-01) 100 tablet2017-05-160000-00-00NoNoCurrent