Oxycodone Hydrochloride Oral Solution

Product NDC: 13107-262
Requested package NDC: 13107-262-57
11-digit product format: 131070262
Labeler code: 13107
Product ID: 13107-262_b0905edb-577e-4e2e-ab2f-c7f5c673b0e1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone Hydrochloride Oral Solution
Dosage form: SOLUTION
Route: ORAL
Labeler: Aurolife Pharma, LLC
Application: ANDA212429
Marketing category: ANDA
Marketing start: 2020-01-27
Substance: OXYCODONE HYDROCHLORIDE
Active strength: 100 mg/5mL
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

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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212429-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2020-01-27
A212429-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL			2020-01-27

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 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	2020-01-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	2020-01-27	`87673890dc5c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A212429-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A212429-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212429-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A212429-002	AA	1	`c0c555d07b60…`

Additional Listing Data#

Finished product: Yes
Brand name base: Oxycodone Hydrochloride Oral Solution
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYCODONE HYDROCHLORIDE	100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049604	Internal RxNorm lookup
1049615	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
0b3fa92e-8351-4401-860d-4bba8a7155e6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
b8cd3792-f010-440e-ac63-7713119fde04	Product name	9	20220110
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
b7a189a6-82e9-f884-a16b-8cdc7e7d1556	Product name	6	20170913
5da64f4c-1e90-423d-af7a-5a52bb3e823e	Product name	4	20170726
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
8a245632-e24f-4ccc-b671-995d89c96ebc	Product name	1	20141203
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
7fa873c5-fb27-7119-0a05-634ad477dea7	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13107-262-57	2024-07-31	C162847	48780-1	f386c649-e519-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE ORAL SOLUTION. Oxycodone Hydrochloride oral solution, USP CII Initial U.S. Approval: 1950
13107-262-57	2023-01-30	C162847	48780-1	f386c649-e519-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE ORAL SOLUTION. Oxycodone Hydrochloride oral solution, USP CII Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13107-262-57	Oxycodone Hydrochloride Oral Solution	1 in 1 CARTON	SOLUTION	1		3
13107-262-57	Oxycodone Hydrochloride Oral Solution	30 mL in 1 BOTTLE	SOLUTION	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13107-262	OXYCODONE HYDROCHLORIDE ORAL SOLUTION SOLUTION [AUROLIFE PHARMA, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20240802_0b3fa92e-8351-4401-860d-4bba8a7155e6.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone Hydrochloride Oral Solution	OXYCODONE HYDROCHLORIDE ORAL SOLUTION	Aurolife Pharma, LLC	0b3fa92e-8351-4401-860d-4bba8a7155e6	2024-01-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212429 application number: ANDA212429 ndc (package): 13107-262-57 ndc (product): 13107-262 ndc11 (package): 13107026257

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE	124-90-3	OXYCODONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049615	oxyCODONE HCl 20 MG in 1 mL Concentrate for Oral Solution	PSN	0b3fa92e-8351-4401-860d-4bba8a7155e6	3
1049604	oxyCODONE HCl 5 MG in 5 mL Oral Solution	PSN	0b3fa92e-8351-4401-860d-4bba8a7155e6	3
1049604	oxycodone hydrochloride 1 MG/ML Oral Solution	SCD	0b3fa92e-8351-4401-860d-4bba8a7155e6	3
1049615	oxycodone hydrochloride 20 MG/ML Oral Solution	SCD	0b3fa92e-8351-4401-860d-4bba8a7155e6	3
1049615	oxycodone hydrochloride 20 MG per 1 ML Concentrate for Oral Solution	SY	0b3fa92e-8351-4401-860d-4bba8a7155e6	3
1049604	oxycodone hydrochloride 5 MG per 5 ML Oral Solution	SY	0b3fa92e-8351-4401-860d-4bba8a7155e6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13107-262-57	13107026257	1 BOTTLE in 1 CARTON (13107-262-57) / 30 mL in 1 BOTTLE	1 bottle	2020-01-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxycodone Hydrochloride Oral Solution	Aurolife Pharma, LLC \| Aurolife Pharma LLC	2024-01-18	Human Prescription Drug Label	3