FDA.reportPublic FDA data

Oxycodone Hydrochloride

Product NDC
60760-956
11-digit product format
607600956
Labeler code
60760
Product ID
60760-956_3ca9e2b4-da38-7408-e063-6294a90a0057
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA077712
Marketing category
ANDA
Marketing start
2024-09-10
Substance
OXYCODONE HYDROCHLORIDE
Active strength
15 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
A077712-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-31
A077712-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-31
A077712-003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-02
A077712-004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-13
A077712-005OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077712-001AB
A077712-002AB
A077712-003AB
A077712-004AB
A077712-005AB

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 06:07:402026-07A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-13caaa826d4ba7…
2026-08-18 06:07:402026-07A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-132680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077712-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077712-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077712-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077712-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077712-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077712-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077712-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-005AB12680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE15 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049611Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ca9f0d9-a40d-4416-e063-6394a90aec8bAvailable 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
60760-956-30Oxycodone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET301
60760-956-60Oxycodone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET601
60760-956-90Oxycodone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-956-30EA - Each60760-956fdccf436-1e0c-401e-847b-50deaa5f3df112025-09-12
60760-956-60EA - Each60760-956a3c8d84d-77fd-4817-8111-212163fecacb12025-09-12
60760-956-90EA - Each60760-956f48f184d-0f16-4784-ab26-afbf7cee2fd212025-09-12

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEStrides Pharma Science Limitedf3116ebf-d72c-4e98-aa50-006be4770c862026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEAsclemed USA, Inc.056bdaac-4a43-42f0-9435-f349d3ccc1282025-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDERedpharm Drug439c2de6-3ea5-e829-e063-6294a90aa77d2025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack08977126-9671-4d87-9724-1599ca86e1812025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY3ca9f0d9-a40d-4416-e063-6394a90aec8b2025-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
ndc (product): 60760-956
Oxycodone HCLOXYCODONE HCLDirect_Rx3245cd2f-8ad0-b755-e063-6394a90a603c2025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HCLOXYCODONE HCLDirect_Rx3a849aeb-b72c-5cde-e063-6394a90a97682025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HCLOXYCODONE HCLDirect_Rx32323565-5add-96a9-e063-6294a90a5b4e2025-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HCLOXYCODONE HCLDirect_Rx323148b2-809a-db11-e063-6294a90abe362025-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049611oxyCODONE HCl 15 MG Oral TabletPSN3ca9f0d9-a40d-4416-e063-6394a90aec8b1
1049611oxycodone hydrochloride 15 MG Oral TabletSCD3ca9f0d9-a40d-4416-e063-6394a90aec8b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-956-306076009563030 TABLET in 1 BOTTLE, PLASTIC (60760-956-30) 30 tablet2025-08-19NoNoCurrent
60760-956-606076009566060 TABLET in 1 BOTTLE, PLASTIC (60760-956-60) 60 tablet2025-08-19NoNoCurrent
60760-956-906076009569090 TABLET in 1 BOTTLE, PLASTIC (60760-956-90) 90 tablet2025-08-19NoNoCurrent