Oxycodone Hydrochloride

Product NDC
10702-023
11-digit product format
107020023
Labeler code
10702
Product ID
10702-023_437f25fb-bd72-c6d8-e063-6294a90a42d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
KVK-TECH, INC.
Application
ANDA202773
Marketing category
ANDA
Marketing start
2015-08-20
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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202773-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202773-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-173f01610625f2…
2019-09-15 20:21 UTC2019-09A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202773-001OXYCODONE HYDROCHLORIDE5MGCAPSULE / ORALAB2015-08-17e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202773-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202773-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202773-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202773-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202773-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202773-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202773-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202773-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202773-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202773-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202773-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202773-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202773-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202773-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202773-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202773-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202773-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202773-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202773-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202773-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202773-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202773-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202773-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202773-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202773-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202773-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202773-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202773-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202773-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202773-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202773-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202773-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202773-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202773-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202773-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202773-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202773-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202773-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202773-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202773-001AB1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE5 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
1049696Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
338b5391-e5f7-40a2-8b15-57f47cbc4813Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-023-01Oxycodone Hydrochloride100 in 1 BOTTLECAPSULE10011
10702-023-06Oxycodone Hydrochloride60 in 1 BOTTLECAPSULE6011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-023-01EA - Each10702-0230240cdb7-c238-49ca-adba-0e504bbcedcf12015-09-10
10702-023-06EA - Each10702-023f926a224-fcaf-4856-aca3-553a87efd77412015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]3
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OXYCODONE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OXYCODONE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOXYCODONE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OXYCODONE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LOXYCODONE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXYCODONE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-023OXYCODONE HYDROCHLORIDE CAPSULE [KVK-TECH, INC.]10Current NDC, Legacy NDC, 2 package rows20240502_338b5391-e5f7-40a2-8b15-57f47cbc4813.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 HYDROCHLORIDEKVK-TECH, INC.338b5391-e5f7-40a2-8b15-57f47cbc48132025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202773
application number: ANDA202773
ndc (product): 10702-023

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049696oxyCODONE HCl 5 MG Oral CapsulePSN338b5391-e5f7-40a2-8b15-57f47cbc481311
1049696oxycodone hydrochloride 5 MG Oral CapsuleSCD338b5391-e5f7-40a2-8b15-57f47cbc481311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-023-0110702002301100 CAPSULE in 1 BOTTLE (10702-023-01) 100 capsule2015-08-200000-00-00NoNoCurrent
10702-023-061070200230660 CAPSULE in 1 BOTTLE (10702-023-06) 60 capsule2015-08-200000-00-00NoNoCurrent