Oxycodone/APAP

Product NDC: 72189-375
11-digit product format: 721890375
Labeler code: 72189
Product ID: 72189-375_4c4c55ca-eef7-8b39-e063-6294a90adf3f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone/APAP
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA201278
Marketing category: ANDA
Marketing start: 2022-09-09
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72189-375-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72189-375-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72189-375-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72189-375-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72189-375-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72189-375-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72189-375-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72189-375-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72189-375-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72189-375-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-375-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-375-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-375-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-375-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A201278-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET / ORAL	AA	2014-08-28
A201278-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28
A201278-003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	AA	2014-08-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A201278-001	AA
A201278-002	AA
A201278-003	AA

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201278-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201278-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201278-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201278-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201278-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201278-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201278-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201278-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201278-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201278-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201278-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201278-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201278-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201278-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201278-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201278-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201278-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201278-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201278-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201278-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201278-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201278-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201278-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201278-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201278-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201278-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201278-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201278-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201278-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201278-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201278-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201278-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201278-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201278-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201278-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201278-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201278-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201278-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201278-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201278-001	AA	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Oxycodone/APAP
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYCODONE HYDROCHLORIDE	325 mg/1
ACETAMINOPHEN	7.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C1ENJ2TE6C	Internal UNII lookup
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049225	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
e84245ca-957f-e85b-e053-2a95a90a836b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
b8cd3792-f010-440e-ac63-7713119fde04	Product name	9	20220110
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3	Product name	9	20190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
b7a189a6-82e9-f884-a16b-8cdc7e7d1556	Product name	6	20170913
5da64f4c-1e90-423d-af7a-5a52bb3e823e	Product name	4	20170726
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6	Product name	1	20170628
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778	Product name	1	20161103
68d3ff71-7803-4cf4-ba84-71ce4712df22	Product name	1	20160620
07e5b999-fda7-79c9-8f77-8380537ade79	Product name	4	20160517
8a245632-e24f-4ccc-b671-995d89c96ebc	Product name	1	20141203
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
7fa873c5-fb27-7119-0a05-634ad477dea7	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
f46484d2-0de6-24f4-bf73-a8f2af6723ef	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
72189-375-30	2025-04-04	Oxycodone/APAP
72189-375-60	2025-04-04	Oxycodone/APAP
72189-375-30	2025-01-30	Oxycodone/APAP
72189-375-60	2025-01-30	Oxycodone/APAP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72189-375-30	Oxycodone/APAP	30 in 1 BOTTLE	TABLET	30	6
72189-375-60	Oxycodone/APAP	60 in 1 BOTTLE	TABLET	60	6
72189-375-72	Oxycodone/APAP	120 in 1 BOTTLE	TABLET	120	6
72189-375-90	Oxycodone/APAP	90 in 1 BOTTLE	TABLET	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-375-30	EA - Each	72189-375	caf72ba9-d4d3-4c1d-9c9c-4f53cec7b3f6	1	2023-01-09
72189-375-60	EA - Each	72189-375	612fb765-ccef-426c-b4a9-4de96aead2bf	1	2022-10-06
72189-375-90	EA - Each	72189-375	910934df-69f2-49fc-9071-917b034d0965	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-375	OXYCODONE/APAP TABLET [DIRECT_RX]	5	Current NDC, Legacy NDC, 4 package rows	20250409_e84245ca-957f-e85b-e053-2a95a90a836b.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	ac6b4a26-7ead-458e-8a3d-591aa0709343	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	ef2c1fe2-75dd-43cf-871d-540c5e36d363	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	fcb09a57-76d8-413c-801b-8d8ea0c3f1db	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	1c793d37-cbc9-4d76-a84a-d076b5101143	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	St. Mary's Medical Park Pharmacy	3cd2e535-dd11-4bfb-e063-6394a90a9fbc	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	4d9e7c39-3e71-48c7-87c7-302db1835f11	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	e6c47385-638a-41cd-93d9-b7ee205aa094	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Rhodes Pharmaceuticals LLC	5999f3c3-3225-4d24-82cd-0b8d7a309587	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	639aba0b-1ef6-415f-9732-ebf52bcc1b86	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	79c3af61-19e7-40e5-bd20-2cea52f0bd3a	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278
Oxycodone/APAP	OXYCODONE/APAP	Direct_Rx	e84245ca-957f-e85b-e053-2a95a90a836b	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278 ndc (product): 72189-375
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	RedPharm Drug	2c6014de-8901-9d83-e063-6294a90ad37b	2025-12-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278
Percocet	OXYCODONE/APAP	Direct_Rx	ee151649-b52a-0a51-e053-2a95a90a6c35	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Proficient Rx LP	ad03068c-1af4-46ce-bdea-c2745b1c1e52	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Asclemed USA, Inc.	3e89f02d-b6e7-4641-82d4-f756518a8914	2022-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Asclemed USA, Inc.	0dcb491a-54e8-486b-9575-788525a178cf	2021-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE	124-90-3	OXYCODONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049225	oxyCODONE 7.5 MG / acetaminophen 325 MG Oral Tablet	PSN	e84245ca-957f-e85b-e053-2a95a90a836b	6
1049225	acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet	SCD	e84245ca-957f-e85b-e053-2a95a90a836b	6
1049225	APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet	SY	e84245ca-957f-e85b-e053-2a95a90a836b	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-375-30	72189037530	30 TABLET in 1 BOTTLE (72189-375-30)	30 tablet	2022-09-09	0000-00-00	No	No	Current
72189-375-60	72189037560	60 TABLET in 1 BOTTLE (72189-375-60)	60 tablet	2022-09-09	0000-00-00	No	No	Current
72189-375-72	72189037572	120 TABLET in 1 BOTTLE (72189-375-72)	120 tablet	2022-09-09		No	No	Current
72189-375-90	72189037590	90 TABLET in 1 BOTTLE (72189-375-90)	90 tablet	2022-09-09		No	No	Current