FDA.reportPublic FDA data

OXYCODONE AND ACETAMINOPHEN

Product NDC
0406-0522
11-digit product format
004060522
Labeler code
0406
Product ID
0406-0522_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; 7.5 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…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 0406-0522

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
ACETAMINOPHEN7.5 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
0406-0522-01OXYCODONE AND ACETAMINOPHEN100 in 1 BOTTLETABLET10047
0406-0522-05OXYCODONE AND ACETAMINOPHEN500 in 1 BOTTLETABLET50047
0406-0522-23OXYCODONE AND ACETAMINOPHEN1 in 1 BLISTER PACKTABLET147
0406-0522-62OXYCODONE AND ACETAMINOPHEN100 in 1 BLISTER PACKTABLET10047

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-0522-01EA - Each0406-0522ac6802fb-e4b7-40db-8c5b-0ecb2d94028f12012-07-24
0406-0522-05EA - Each0406-05220d51d676-1c3d-424f-8689-0ae5ef051d3a12016-03-04
0406-0522-23EA - Each0406-05228c609aea-c1ee-44f9-8d21-fac699f07bd312013-03-03
0406-0522-62EA - Each0406-0522b729025d-81c4-4c99-b974-bc3e20285a3712012-07-24

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 [STAT RX USA LLC]3
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [STAT RX USA LLC]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [STAT RX USA LLC]3
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [STAT RX USA LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [STAT RX USA LLC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [STAT RX USA LLC]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [STAT RX USA LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [STAT RX USA LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [STAT RX USA LLC]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [STAT RX USA LLC]3
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]2
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]2
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-0522OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [SPECGX LLC]46Current NDC, Legacy NDC, 4 package rows20240705_f2137f1a-b49a-40bd-97ac-cd6b36e295f4.zip

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
1049225oxyCODONE 7.5 MG / acetaminophen 325 MG Oral TabletPSN00109d18-397a-4c10-a28b-836d56d718293
1049225acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCD00109d18-397a-4c10-a28b-836d56d718293
1049225APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSY00109d18-397a-4c10-a28b-836d56d718293
1049225oxyCODONE 7.5 MG / acetaminophen 325 MG Oral TabletPSN29a8d7c5-288e-4305-8d64-42d8158ae4cd2
1049225acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCD29a8d7c5-288e-4305-8d64-42d8158ae4cd2
1049225APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSY29a8d7c5-288e-4305-8d64-42d8158ae4cd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-0522-0100406052201100 TABLET in 1 BOTTLE (0406-0522-01) 100 tablet2004-06-300000-00-00NoNoCurrent
0406-0522-0500406052205500 TABLET in 1 BOTTLE (0406-0522-05) 500 tablet2004-06-300000-00-00NoNoCurrent
0406-0522-23004060522231 TABLET in 1 BLISTER PACK (0406-0522-23) 1 tablet2004-06-300000-00-00NoNoCurrent
0406-0522-6200406052262100 TABLET in 1 BLISTER PACK (0406-0522-62) 100 tablet2004-06-300000-00-00NoNoCurrent