Oxycodone Hydrochloride

Product NDC: 43386-920
11-digit product format: 433860920
Labeler code: 43386
Product ID: 43386-920_e5a8251c-8fc6-4b34-a01f-1706ebda9f94
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA204603
Marketing category: ANDA
Marketing start: 2015-04-29
Substance: OXYCODONE HYDROCHLORIDE
Active strength: 20 mg/mL
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 42.

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
A204603-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL			2015-04-29

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 · 42 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
2026-08-18 06:07:40	2026-07	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204603-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204603-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204603-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204603-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204603-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204603-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204603-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204603-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204603-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204603-001	AA	1	`ea99ee380514…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYCODONE HYDROCHLORIDE	20 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
3eddd18b-695a-4e53-a76c-f6779515b918	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
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
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
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
43386-920-60	Oxycodone Hydrochloride	1 in 1 CARTON	SOLUTION	1		8
43386-920-60	Oxycodone Hydrochloride	30 mL in 1 BOTTLE	SOLUTION	30		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43386-920-60	ML - Milliliter	43386-920	b76d9d92-6b66-4364-b244-ecfc18e0994a	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYCODONE HYDROCHLORIDE	ACTIVE INGREDIENT	C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC]	2
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC]	2
BERRY	INACTIVE INGREDIENT	FV3431923Z	OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC]	2
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	OXYCODONE HYDROCHLORIDE SOLUTION [GAVIS PHARMACEUTICALS, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43386-920	OXYCODONE HYDROCHLORIDE SOLUTION [LUPIN PHARMACEUTICALS, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20241204_3eddd18b-695a-4e53-a76c-f6779515b918.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	OXYCODONE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	3eddd18b-695a-4e53-a76c-f6779515b918	2024-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204603 application number: ANDA204603 ndc (product): 43386-920

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	3eddd18b-695a-4e53-a76c-f6779515b918	8
1049615	oxycodone hydrochloride 20 MG/ML Oral Solution	SCD	3eddd18b-695a-4e53-a76c-f6779515b918	8
1049615	oxycodone hydrochloride 20 MG per 1 ML Concentrate for Oral Solution	SY	3eddd18b-695a-4e53-a76c-f6779515b918	8
1049615	oxyCODONE HCl 20 MG in 1 mL Concentrate for Oral Solution	PSN	d586b60e-c111-4fc9-ac04-64f3b7d387b8	5
1049615	oxycodone hydrochloride 20 MG/ML Oral Solution	SCD	d586b60e-c111-4fc9-ac04-64f3b7d387b8	5
1049615	oxycodone hydrochloride 20 MG per 1 ML Concentrate for Oral Solution	SY	d586b60e-c111-4fc9-ac04-64f3b7d387b8	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43386-920-60	43386092060	1 BOTTLE in 1 CARTON (43386-920-60) / 30 mL in 1 BOTTLE	1 bottle	2015-04-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxycodone Hydrochloride	Lupin Pharmaceuticals, Inc. \| Novel Laboratories, Inc.	2024-09-12	HUMAN PRESCRIPTION DRUG LABEL	8
Oxycodone Hydrochloride	ATLANTIC BIOLOGICALS CORP.	2021-01-28	HUMAN PRESCRIPTION DRUG LABEL	5