FDA.reportPublic FDA data

OXYCODONE AND ACETAMINOPHEN

Product NDC
0406-0523
11-digit product format
004060523
Labeler code
0406
Product ID
0406-0523_38cc2423-8e75-4007-b224-75aa920582d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone hydrochloride and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA040545
Marketing category
ANDA
Marketing start
2004-06-30
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325; 10 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040545-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;7.5MGTABLET / ORALAA2004-06-30
A040545-002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;10MGTABLET / ORALAA2004-06-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A040545-001AA
A040545-002AA

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040545-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2004-06-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A040545-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2004-06-30782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040545-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040545-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040545-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040545-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040545-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040545-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040545-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040545-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040545-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040545-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040545-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040545-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040545-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040545-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040545-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040545-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040545-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040545-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040545-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040545-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040545-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040545-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040545-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040545-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040545-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040545-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040545-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040545-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040545-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040545-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040545-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040545-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040545-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040545-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040545-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040545-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040545-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040545-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040545-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040545-002AA1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE325 mg/1
ACETAMINOPHEN10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
C1ENJ2TE6CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049214Internal RxNorm lookup
1049221Internal RxNorm lookup
1049225Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f2137f1a-b49a-40bd-97ac-cd6b36e295f4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
b8cd3792-f010-440e-ac63-7713119fde04Product name920220110
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3Product name920190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
b7a189a6-82e9-f884-a16b-8cdc7e7d1556Product name620170913
5da64f4c-1e90-423d-af7a-5a52bb3e823eProduct name420170726
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6Product name120170628
377068df-225f-7318-a910-a1987cdfa361Product name320170608
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
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
7fa873c5-fb27-7119-0a05-634ad477dea7Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
f46484d2-0de6-24f4-bf73-a8f2af6723efProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0406-0523-01OXYCODONE AND ACETAMINOPHEN100 in 1 BOTTLETABLET10047
0406-0523-05OXYCODONE AND ACETAMINOPHEN500 in 1 BOTTLETABLET50047
0406-0523-23OXYCODONE AND ACETAMINOPHEN1 in 1 BLISTER PACKTABLET147
0406-0523-62OXYCODONE AND ACETAMINOPHEN100 in 1 BLISTER PACKTABLET10047

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-0523-01EA - Each0406-052348077e58-f4ed-476e-941a-3fb4c2c1dca912012-07-24
0406-0523-05EA - Each0406-05239384b2fc-e93d-49ae-9fc8-a7df106b82c312016-03-04
0406-0523-23EA - Each0406-052337cca248-643b-4cd8-8014-b2bd9b1c9ca112013-03-03
0406-0523-62EA - Each0406-052383473388-be13-4062-a64f-abd7a7d0c7c212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MALLINCKRODT, INC.]23
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MALLINCKRODT, INC.]23
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MALLINCKRODT, INC.]23
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MALLINCKRODT, INC.]23
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MALLINCKRODT, INC.]23
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MALLINCKRODT, INC.]23
POVIDONESINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MALLINCKRODT, INC.]23
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MALLINCKRODT, INC.]23
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MALLINCKRODT, INC.]23
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MALLINCKRODT, INC.]23
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]7
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]7
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]7
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]7
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]7
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-0523OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [SPECGX LLC]46Current NDC, Legacy NDC, 4 package rows20240705_f2137f1a-b49a-40bd-97ac-cd6b36e295f4.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 AND ACETAMINOPHENOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSpecGx LLCf2137f1a-b49a-40bd-97ac-cd6b36e295f42026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040545
application number: ANDA040545
ndc (product): 0406-0523

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSNf2137f1a-b49a-40bd-97ac-cd6b36e295f447
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSNf2137f1a-b49a-40bd-97ac-cd6b36e295f447
1049225oxyCODONE 7.5 MG / acetaminophen 325 MG Oral TabletPSNf2137f1a-b49a-40bd-97ac-cd6b36e295f447
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCDf2137f1a-b49a-40bd-97ac-cd6b36e295f447
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCDf2137f1a-b49a-40bd-97ac-cd6b36e295f447
1049225acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCDf2137f1a-b49a-40bd-97ac-cd6b36e295f447
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSYf2137f1a-b49a-40bd-97ac-cd6b36e295f447
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSYf2137f1a-b49a-40bd-97ac-cd6b36e295f447
1049225APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSYf2137f1a-b49a-40bd-97ac-cd6b36e295f447
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN2cb9090d-76dd-44a2-9590-37c6e7ed495b7
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSN2cb9090d-76dd-44a2-9590-37c6e7ed495b7
1049225oxyCODONE 7.5 MG / acetaminophen 325 MG Oral TabletPSN2cb9090d-76dd-44a2-9590-37c6e7ed495b7
1049233oxyCODONE 7.5 MG / acetaminophen 500 MG Oral TabletPSN2cb9090d-76dd-44a2-9590-37c6e7ed495b7
1049270oxyCODONE HCl 10 MG / acetaminophen 650 MG Oral TabletPSN2cb9090d-76dd-44a2-9590-37c6e7ed495b7
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD2cb9090d-76dd-44a2-9590-37c6e7ed495b7
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCD2cb9090d-76dd-44a2-9590-37c6e7ed495b7
1049225acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCD2cb9090d-76dd-44a2-9590-37c6e7ed495b7
1049233acetaminophen 500 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCD2cb9090d-76dd-44a2-9590-37c6e7ed495b7
1049270acetaminophen 650 MG / oxycodone hydrochloride 10 MG Oral TabletSCD2cb9090d-76dd-44a2-9590-37c6e7ed495b7
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY2cb9090d-76dd-44a2-9590-37c6e7ed495b7
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSY2cb9090d-76dd-44a2-9590-37c6e7ed495b7
1049225APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSY2cb9090d-76dd-44a2-9590-37c6e7ed495b7
1049233APAP 500 MG / oxycodone hydrochloride 7.5 MG Oral TabletSY2cb9090d-76dd-44a2-9590-37c6e7ed495b7
1049270APAP 650 MG / oxycodone hydrochloride 10 MG Oral TabletSY2cb9090d-76dd-44a2-9590-37c6e7ed495b7
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSNf53bfa4e-e4a4-cfb6-e053-2995a90a7ba14
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCDf53bfa4e-e4a4-cfb6-e053-2995a90a7ba14
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSYf53bfa4e-e4a4-cfb6-e053-2995a90a7ba14
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSN77a4aae7-a0cc-4f86-b91f-ec4112c6d3be1
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCD77a4aae7-a0cc-4f86-b91f-ec4112c6d3be1
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSY77a4aae7-a0cc-4f86-b91f-ec4112c6d3be1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-0523-0100406052301100 TABLET in 1 BOTTLE (0406-0523-01) 100 tablet2004-06-300000-00-00NoNoCurrent
0406-0523-0500406052305500 TABLET in 1 BOTTLE (0406-0523-05) 500 tablet2004-06-300000-00-00NoNoCurrent
0406-0523-23004060523231 TABLET in 1 BLISTER PACK (0406-0523-23) 1 tablet2004-06-300000-00-00NoNoCurrent
0406-0523-6200406052362100 TABLET in 1 BLISTER PACK (0406-0523-62) 100 tablet2004-06-300000-00-00NoNoCurrent