OXYCODONE HYDROCHLORIDE

Product NDC
10702-009
11-digit product format
107020009
Labeler code
10702
Product ID
10702-009_31f901b4-04ad-38aa-e063-6294a90ac708
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
KVK-TECH,INC
Application
ANDA091393
Marketing category
ANDA
Marketing start
2013-10-18
Substance
OXYCODONE HYDROCHLORIDE
Active strength
30 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
A091393-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-31
A091393-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-31
A091393-003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-31
A091393-004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-31
A091393-005OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091393-001AB
A091393-002AB
A091393-003AB
A091393-004AB
A091393-005AB

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 UTC2026-02A091393-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091393-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091393-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091393-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091393-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091393-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091393-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091393-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091393-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091393-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091393-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091393-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091393-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091393-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091393-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-315bbf6a4d5a75…

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 UTC2026-02A091393-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091393-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091393-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091393-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091393-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091393-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091393-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091393-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091393-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091393-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091393-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091393-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091393-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091393-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091393-005AB15bbf6a4d5a75…

Additional Listing Data#

Finished product
Yes
Brand name base
OXYCODONE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE30 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
e73897d6-b920-4300-a564-5dbc9c8e9fe9Available 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
10702-009-01OXYCODONE HYDROCHLORIDE100 in 1 BOTTLETABLET10015
10702-009-50OXYCODONE HYDROCHLORIDE500 in 1 BOTTLETABLET50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-009-01EA - Each10702-0095fa8b65b-7c62-4ffc-a8c6-8aa77517725812012-07-24
10702-009-50EA - Each10702-00972132602-49b8-45b5-b2cd-26b357fc0c9e12015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KOXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYCODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-009OXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]15Current NDC, Legacy NDC, 2 package rows20250409_e73897d6-b920-4300-a564-5dbc9c8e9fe9.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDESt. Mary's Medical Park Pharmacy3ccf459a-fb11-e137-e063-6394a90a5a802026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch Prepack685d9709-028e-4422-bf0c-fde577b718a22026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEKVK-TECH,INCe73897d6-b920-4300-a564-5dbc9c8e9fe92026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
ndc (product): 10702-009
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY424fdfc7-1c92-2e62-e063-6394a90a136b2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health Packagingaa7ac2bf-d9ed-445d-b394-4d3fe39780ca2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY3cd01fb7-b59c-fc5d-e063-6394a90a21d22025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEDIRECT RXa8206207-ad09-83df-e053-2995a90a78b72025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
Oxycodone HCLOXYCODONE HCLDirect_Rx31189587-a2dc-e0a1-e063-6394a90ae17d2025-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
Oxycodone HydchlorideOXYCODONE HYDCHLORIDEQuality Care Products LLCb9847cc7-67a2-408d-93cf-f9cf420346dd2024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEQuality Care Products LLC4cadb809-157d-49cc-97b4-3276594f19d22024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
Oxycodone HydchlorideOXYCODONE HYDCHLORIDEQuality Care Products LLC28156b13-0ba9-4dc4-be24-9c3070a7e1cc2024-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.17f7946d-e889-b736-e063-6394a90a42e02024-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049683oxyCODONE HCl 10 MG Oral TabletPSNe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049611oxyCODONE HCl 15 MG Oral TabletPSNe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049686oxyCODONE HCl 20 MG Oral TabletPSNe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049618oxyCODONE HCl 30 MG Oral TabletPSNe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049621oxyCODONE HCl 5 MG Oral TabletPSNe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049683oxycodone hydrochloride 10 MG Oral TabletSCDe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049611oxycodone hydrochloride 15 MG Oral TabletSCDe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049686oxycodone hydrochloride 20 MG Oral TabletSCDe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049618oxycodone hydrochloride 30 MG Oral TabletSCDe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049621oxycodone hydrochloride 5 MG Oral TabletSCDe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049683oxyCODONE HCl 10 MG Oral TabletPSNaa7ac2bf-d9ed-445d-b394-4d3fe39780ca10
1049611oxyCODONE HCl 15 MG Oral TabletPSNaa7ac2bf-d9ed-445d-b394-4d3fe39780ca10
1049618oxyCODONE HCl 30 MG Oral TabletPSNaa7ac2bf-d9ed-445d-b394-4d3fe39780ca10
1049621oxyCODONE HCl 5 MG Oral TabletPSNaa7ac2bf-d9ed-445d-b394-4d3fe39780ca10
1049683oxycodone hydrochloride 10 MG Oral TabletSCDaa7ac2bf-d9ed-445d-b394-4d3fe39780ca10
1049611oxycodone hydrochloride 15 MG Oral TabletSCDaa7ac2bf-d9ed-445d-b394-4d3fe39780ca10
1049618oxycodone hydrochloride 30 MG Oral TabletSCDaa7ac2bf-d9ed-445d-b394-4d3fe39780ca10
1049621oxycodone hydrochloride 5 MG Oral TabletSCDaa7ac2bf-d9ed-445d-b394-4d3fe39780ca10
1049611oxyCODONE HCl 15 MG Oral TabletPSN4cadb809-157d-49cc-97b4-3276594f19d29
1049618oxyCODONE HCl 30 MG Oral TabletPSN4cadb809-157d-49cc-97b4-3276594f19d29
1049611oxycodone hydrochloride 15 MG Oral TabletSCD4cadb809-157d-49cc-97b4-3276594f19d29
1049618oxycodone hydrochloride 30 MG Oral TabletSCD4cadb809-157d-49cc-97b4-3276594f19d29
1049618oxyCODONE HCl 30 MG Oral TabletPSN685d9709-028e-4422-bf0c-fde577b718a23
1049618oxycodone hydrochloride 30 MG Oral TabletSCD685d9709-028e-4422-bf0c-fde577b718a23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-009-0110702000901100 TABLET in 1 BOTTLE (10702-009-01) 100 tablet2013-10-180000-00-00NoNoCurrent
10702-009-5010702000950500 TABLET in 1 BOTTLE (10702-009-50) 500 tablet2013-10-180000-00-00NoNoCurrent