Oxycodone Hydrochloride

Product NDC
68094-005
11-digit product format
680940005
Labeler code
68094
Product ID
68094-005_31203769-a951-4d0c-8d60-4cb7715e26e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Precision Dose, Inc.
Application
ANDA203638
Marketing category
ANDA
Marketing start
2016-12-21
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 1.

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
A203638-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2014-06-03
A203638-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-03
A203638-003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2014-06-03
A203638-004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2014-06-03
A203638-005OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2014-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203638-001AB
A203638-002AB
A203638-003AB
A203638-004AB
A203638-005AB

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 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203638-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2014-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203638-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203638-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2014-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203638-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2014-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203638-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2014-06-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203638-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2014-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203638-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203638-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2014-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203638-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2014-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203638-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2014-06-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A203638-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2014-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203638-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203638-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2014-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203638-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2014-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203638-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2014-06-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203638-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2014-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203638-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203638-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2014-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203638-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2014-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203638-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2014-06-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203638-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2014-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203638-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203638-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2014-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203638-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2014-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203638-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2014-06-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203638-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2014-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203638-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203638-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2014-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203638-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2014-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203638-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2014-06-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203638-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2014-06-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203638-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203638-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2014-06-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203638-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2014-06-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203638-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2014-06-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203638-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2014-06-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203638-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2014-06-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203638-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2014-06-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203638-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2014-06-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203638-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2014-06-035bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203638-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203638-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203638-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203638-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203638-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203638-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203638-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203638-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203638-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203638-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203638-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203638-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203638-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203638-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203638-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203638-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203638-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203638-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203638-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203638-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203638-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203638-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203638-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203638-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203638-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203638-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203638-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203638-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203638-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203638-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203638-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203638-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203638-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203638-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203638-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203638-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203638-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203638-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203638-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203638-005AB15bbf6a4d5a75…

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
f849c7cc-fa85-47eb-be30-1be137913bf9Available 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
68094-005-59Oxycodone Hydrochloride10 in 1 BLISTER PACKTABLET107
68094-005-61Oxycodone Hydrochloride10 in 1 CARTONTABLET107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-005-59EA - Each68094-005afba1f95-14ac-469f-9521-13892cd1a5cb12018-02-20
68094-005-61EA - Each68094-005b13b545b-fa08-4135-a865-c32a4abb886412017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-005OXYCODONE HYDROCHLORIDE TABLET [PRECISION DOSE, INC.]7Current NDC, Legacy NDC, 2 package rows20250207_f849c7cc-fa85-47eb-be30-1be137913bf9.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone HydrochlorideOXYCODONEMajor Pharmaceuticals6b6db42b-9821-4aa6-8566-297037d840792026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203638
application number: ANDA203638
Oxycodone HydrochlorideOXYCODONEAmneal Pharmaceuticals LLC094b64b3-cd32-4de5-afb6-ea00d9caad742026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203638
application number: ANDA203638
Oxycodone HydrochlorideOXYCODONERedpharm Drug525001a6-68d8-7ef7-e063-6294a90abc5f2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203638
application number: ANDA203638
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEPrecision Dose, Inc.f849c7cc-fa85-47eb-be30-1be137913bf92024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203638
application number: ANDA203638
ndc (product): 68094-005
Oxycodone HydrochlorideOXYCODONEBryant Ranch Prepackb2510d72-bf63-4c9d-ac5e-7bacd993fa102024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203638
application number: ANDA203638
Oxycodone HydrochlorideOXYCODONEBryant Ranch Prepack232d44d2-3924-4d35-873c-d2aef75e9a412024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203638
application number: ANDA203638
Oxycodone HydrochlorideOXYCODONEBryant Ranch Prepackd248ceba-9492-4348-aa07-31c9c73a36202024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203638
application number: ANDA203638
Oxycodone HydrochlorideOXYCODONEBryant Ranch Prepackbc7fdf7e-ad4e-4a04-b35c-2233cc7e5f152024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203638
application number: ANDA203638
Oxycodone HydrochlorideOXYCODONEBryant Ranch Prepack4e9e945d-5ffc-48de-99fa-3fb36c5bc2b92024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203638
application number: ANDA203638
Oxycodone HydrochlorideOXYCODONEBryant Ranch Prepack9da42120-0214-45cb-bb98-9a7739e72d432024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203638
application number: ANDA203638

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049611oxyCODONE HCl 15 MG Oral TabletPSNf849c7cc-fa85-47eb-be30-1be137913bf97
1049611oxycodone hydrochloride 15 MG Oral TabletSCDf849c7cc-fa85-47eb-be30-1be137913bf97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-005-596809400055910 in 1 BLISTER PACKHistorical
68094-005-616809400056110 BLISTER PACK in 1 CARTON (68094-005-61) / 10 TABLET in 1 BLISTER PACK (68094-005-59) 10 blister pack2016-12-210000-00-00NoNoCurrent