Oxycodone Hydrochloride and Acetaminophen

Product NDC: 29033-405
Requested package NDC: 29033-405-35
11-digit product format: 290330405
Labeler code: 29033
Product ID: 29033-405_778f64a4-c8fa-4720-ac5e-787fbcd4768c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone Hydrochloride and Acetaminophen
Dosage form: SOLUTION
Route: ORAL
Labeler: Nostrum Laboratories, Inc.
Application: ANDA201448
Marketing category: ANDA
Marketing start: 2021-12-01
Marketing end: 0000-00-00
Substance: OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength: 5 mg/5mL; mg/5mL
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	29033-405	29033-405-35	I	Inactivated by FDA		2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201448-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG/5ML;5MG/5ML	SOLUTION / ORAL			2021-08-26

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL		2021-08-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL		2021-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL		2021-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL		2021-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	2021-08-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201448-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL		2021-08-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A201448-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201448-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201448-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201448-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201448-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201448-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201448-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201448-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201448-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201448-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201448-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201448-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201448-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201448-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201448-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A201448-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201448-001	AA	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201448-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201448-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201448-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201448-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201448-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201448-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201448-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201448-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201448-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201448-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201448-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201448-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201448-001	AA	1	`cb3db0bc1861…`

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
29033-405-35	Oxycodone Hydrochloride and Acetaminophen	500 mL in 1 BOTTLE	SOLUTION	500		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29033-405-35	ML - Milliliter	29033-405	c82cda03-eb23-4512-a78d-9728af476ee8	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29033-405	OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN SOLUTION [NOSTRUM LABORATORIES, INC.]	1	Legacy NDC, 1 package rows	20211201_b3f5d46d-d807-4db9-abbd-9f0da4548283.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049580	oxyCODONE HCl 5 MG / acetaminophen 325 MG in 5 mL Oral Solution	PSN	b3f5d46d-d807-4db9-abbd-9f0da4548283	1
1049580	acetaminophen 65 MG/ML / oxycodone hydrochloride 1 MG/ML Oral Solution	SCD	b3f5d46d-d807-4db9-abbd-9f0da4548283	1
1049580	APAP 325 MG / oxycodone hydrochloride 5 MG per 5 ML Oral Solution	SY	b3f5d46d-d807-4db9-abbd-9f0da4548283	1
1049580	APAP 65 MG/ML / Oxycodone Hydrochloride 1 MG/ML Oral Solution	SY	b3f5d46d-d807-4db9-abbd-9f0da4548283	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29033-405-35	29033040535	500 mL in 1 BOTTLE (29033-405-35)	500 ml	2021-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxycodone Hydrochloride and Acetaminophen Oral Solution 5 mg/325 mg per 5 mL Rx Only	Nostrum Laboratories, Inc.	2021-09-08	Human Prescription Drug Label	1