Oxycodone and Acetaminophen

Product NDC: 31722-194
11-digit product format: 317220194
Labeler code: 31722
Product ID: 31722-194_560e8cac-91f2-47dc-ac17-4d511598c49a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA207419
Marketing category: ANDA
Marketing start: 2017-04-11
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: 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A207419-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22
A207419-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET / ORAL	AA	2017-03-22
A207419-003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22
A207419-004	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	AA	2017-03-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A207419-001	AA
A207419-002	AA
A207419-003	AA
A207419-004	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 5 · 164 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	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A207419-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207419-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207419-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207419-004	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207419-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207419-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207419-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207419-004	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207419-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207419-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207419-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207419-004	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207419-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207419-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207419-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207419-004	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207419-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207419-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207419-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207419-004	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207419-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207419-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207419-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207419-004	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207419-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207419-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207419-003	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207419-004	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207419-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207419-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207419-003	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207419-004	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207419-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207419-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207419-003	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207419-004	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207419-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207419-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207419-003	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207419-004	AA	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Oxycodone and Acetaminophen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYCODONE HYDROCHLORIDE	325 mg/1
ACETAMINOPHEN	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049214	Internal RxNorm lookup
1049221	Internal RxNorm lookup
1049225	Internal RxNorm lookup
1049635	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
2a49ee34-6f1d-4ed3-8daa-343723d2a2be	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
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
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3	Product name	9	20190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
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
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
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
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
7fa873c5-fb27-7119-0a05-634ad477dea7	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	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
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508
f46484d2-0de6-24f4-bf73-a8f2af6723ef	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
31722-194-01	Oxycodone and Acetaminophen	100 in 1 BOTTLE	TABLET	100		2
31722-194-05	Oxycodone and Acetaminophen	500 in 1 BOTTLE	TABLET	500		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-194-01	EA - Each	31722-194	c92474d1-010a-4d2f-b8e3-6833ae64ecab	1	2017-05-03
31722-194-05	EA - Each	31722-194	8f38bb5b-6801-4488-bb9f-43926398ac6c	1	2017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-194	OXYCODONE AND ACETAMINOPHEN TABLET [CAMBER PHARMACEUTICALS, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20180306_2a49ee34-6f1d-4ed3-8daa-343723d2a2be.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Camber Pharmaceuticals, Inc.	42777191-0454-4ccb-8fc3-8b18b0ee43f7	2025-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Direct_Rx	90a11364-fc42-e94e-e053-2a95a90a9782	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Asclemed USA, Inc.	71c7a627-6ed9-4f49-8cdc-b3228c021e64	2025-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Direct_Rx	e4e27022-581e-ba8c-e053-2a95a90a1ae4	2025-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	9e4024f4-0f60-dfef-e053-2995a90ac366	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	925f9787-3d1c-0189-e053-2a95a90a2972	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	4a873428-bb5a-4e48-9185-2a27f289110d	2024-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	88d05136-7b04-4b25-af1c-6bc72fdbcbd7	2024-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	96173ce4-4836-43ae-9797-5246f830643a	2024-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	3791abd3-fcdf-4c8d-b46d-db6e5c805770	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	0c85d1b8-ea42-421d-a305-4d338b47150f	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	4da8a7bd-0d2e-452c-afb5-fed4e230a9bd	2024-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	XLCare Pharmaceuticals, Inc.	7f3c6dd7-6bc8-450e-aded-997f9cf63a8f	2024-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Proficient Rx LP	78933d4a-d78a-43bc-9052-a032901ee050	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Proficient Rx LP	5df7c033-0f31-45bc-8c34-3da45635e66d	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Proficient Rx LP	484a4323-0758-439d-844f-f04d7e5ef6f3	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Camber Pharmaceuticals, Inc.	2a49ee34-6f1d-4ed3-8daa-343723d2a2be	2018-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419 ndc (product): 31722-194

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
1049214	oxyCODONE 10 MG / acetaminophen 325 MG Oral Tablet	PSN	2a49ee34-6f1d-4ed3-8daa-343723d2a2be	2
1049214	oxyCODONE 10 MG / acetaminophen 325 MG Oral Tablet	PSN	5df7c033-0f31-45bc-8c34-3da45635e66d	2
1049221	oxyCODONE 5 MG / acetaminophen 325 MG Oral Tablet	PSN	2a49ee34-6f1d-4ed3-8daa-343723d2a2be	2
1049225	oxyCODONE 7.5 MG / acetaminophen 325 MG Oral Tablet	PSN	2a49ee34-6f1d-4ed3-8daa-343723d2a2be	2
1049635	oxyCODONE HCl 2.5 MG / acetaminophen 325 MG Oral Tablet	PSN	2a49ee34-6f1d-4ed3-8daa-343723d2a2be	2
1049214	acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet	SCD	2a49ee34-6f1d-4ed3-8daa-343723d2a2be	2
1049214	acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet	SCD	5df7c033-0f31-45bc-8c34-3da45635e66d	2
1049635	acetaminophen 325 MG / oxycodone hydrochloride 2.5 MG Oral Tablet	SCD	2a49ee34-6f1d-4ed3-8daa-343723d2a2be	2
1049221	acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet	SCD	2a49ee34-6f1d-4ed3-8daa-343723d2a2be	2
1049225	acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet	SCD	2a49ee34-6f1d-4ed3-8daa-343723d2a2be	2
1049214	APAP 325 MG / oxycodone hydrochloride 10 MG Oral Tablet	SY	2a49ee34-6f1d-4ed3-8daa-343723d2a2be	2
1049214	APAP 325 MG / oxycodone hydrochloride 10 MG Oral Tablet	SY	5df7c033-0f31-45bc-8c34-3da45635e66d	2
1049635	APAP 325 MG / Oxycodone Hydrochloride 2.5 MG Oral Tablet	SY	2a49ee34-6f1d-4ed3-8daa-343723d2a2be	2
1049221	APAP 325 MG / oxycodone hydrochloride 5 MG Oral Tablet	SY	2a49ee34-6f1d-4ed3-8daa-343723d2a2be	2
1049225	APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet	SY	2a49ee34-6f1d-4ed3-8daa-343723d2a2be	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
31722-194-01	31722019401	100 TABLET in 1 BOTTLE (31722-194-01)	100 tablet	2017-04-11	0000-00-00	No	No	Current
31722-194-05	31722019405	500 TABLET in 1 BOTTLE (31722-194-05)	500 tablet	2017-04-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxycodone and Acetaminophen Tablets, USP CII Rx Only	Proficient Rx LP	2022-11-01	HUMAN PRESCRIPTION DRUG LABEL	2
Oxycodone and Acetaminophen Tablets, USP CII Rx Only	Bryant Ranch Prepack	2020-09-20	HUMAN PRESCRIPTION DRUG LABEL	6
Oxycodone and Acetaminophen Tablets, USP CII Rx Only	Camber Pharmaceuticals, Inc. \| Ascent Pharmaceuticals, Inc.	2018-02-20	HUMAN PRESCRIPTION DRUG LABEL	2