Oxycodone Hydrochloride

Product NDC: 63629-1930
Requested package NDC: 63629-1930-1
11-digit product format: 636291930
Labeler code: 63629
Product ID: 63629-1930_fc0af6c2-4f73-40eb-9130-e61a23976f4c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA207418
Marketing category: ANDA
Marketing start: 2017-08-08
Substance: OXYCODONE HYDROCHLORIDE
Active strength: 30 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

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A207418-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2017-08-07
A207418-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2017-08-07
A207418-003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2025-11-14
A207418-004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2025-11-14
A207418-005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2025-11-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A207418-001	AB
A207418-002	AB
A207418-003	AB
A207418-004	AB
A207418-005	AB

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 3 · 91 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	A207418-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2017-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207418-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2017-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207418-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207418-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207418-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2025-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207418-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2017-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207418-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2017-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207418-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207418-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207418-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2025-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207418-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2017-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207418-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2017-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207418-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2017-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207418-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2017-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207418-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2017-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207418-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2017-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207418-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2017-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207418-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2017-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207418-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2017-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207418-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2017-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207418-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2017-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207418-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2017-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207418-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2017-08-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207418-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2017-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207418-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2017-08-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207418-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2017-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207418-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2017-08-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207418-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2017-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207418-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2017-08-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207418-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2017-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207418-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2017-08-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207418-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2017-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207418-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2017-08-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207418-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2017-08-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207418-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2017-08-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207418-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2017-08-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207418-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2017-08-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207418-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2017-08-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207418-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2017-08-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207418-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2017-08-07	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 91 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	A207418-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207418-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207418-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207418-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207418-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207418-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207418-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207418-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207418-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207418-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207418-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207418-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207418-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207418-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207418-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207418-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207418-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207418-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207418-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207418-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207418-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207418-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207418-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207418-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207418-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207418-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207418-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207418-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207418-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207418-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207418-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207418-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207418-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207418-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207418-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207418-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207418-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207418-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207418-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207418-002	AB	1	`4b0b4de00fa7…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYCODONE HYDROCHLORIDE	30 mg/1

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
1049618	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
35030c55-47e6-44cb-9d96-0c3cd5d0c238	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-1930-1	Oxycodone Hydrochloride	500 in 1 BOTTLE	TABLET	500		104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1930-1	EA - Each	63629-1930	0ebde1d6-6c31-4a7a-9895-cdaaacbe72e5	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-1930	OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 1 package rows	20231102_35030c55-47e6-44cb-9d96-0c3cd5d0c238.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	57afed61-79db-ca43-e063-6394a90a68eb	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207418 application number: ANDA207418
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	27124cdf-a3e8-474c-9c1e-6fa48f6ddc05	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207418 application number: ANDA207418
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	ff7f1268-ddb7-4742-beee-8b12966fe8f9	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207418 application number: ANDA207418
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	35030c55-47e6-44cb-9d96-0c3cd5d0c238	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207418 application number: ANDA207418 ndc (package): 63629-1930-1 ndc (product): 63629-1930 ndc11 (package): 63629193001
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Camber Pharmaceuticals Inc	01db4606-d49c-4b10-a78a-1cf41880a9fb	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207418 application number: ANDA207418
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc	e5c8e72d-4ac5-4ca3-9557-6a659d4d8338	2021-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207418 application number: ANDA207418

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
1049618	oxyCODONE HCl 30 MG Oral Tablet	PSN	35030c55-47e6-44cb-9d96-0c3cd5d0c238	104
1049618	oxycodone hydrochloride 30 MG Oral Tablet	SCD	35030c55-47e6-44cb-9d96-0c3cd5d0c238	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-1930-1	63629193001	500 TABLET in 1 BOTTLE (63629-1930-1)	500 tablet	2017-08-08	0000-00-00	No	No	Current