Oxycodone Hydrochloride

Product NDC: 71335-0981
11-digit product format: 713350981
Labeler code: 71335
Product ID: 71335-0981_dca003cc-0feb-46b3-aedc-73c20fc7f798
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA203638
Marketing category: ANDA
Marketing start: 2012-10-30
Substance: OXYCODONE HYDROCHLORIDE
Active strength: 5 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

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0981-9	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0981-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0981-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0981-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0981-6	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0981-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0981-5	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0981-7	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0981-8	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0981-9	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0981-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0981-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0981-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0981-6	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0981-4	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0981-5	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0981-7	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0981-8	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0981-9	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0981-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0981-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0981-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0981-6	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0981-4	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0981-5	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0981-7	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0981-8	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A203638-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03
A203638-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03
A203638-003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03
A203638-004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03
A203638-005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203638-001	AB
A203638-002	AB
A203638-003	AB
A203638-004	AB
A203638-005	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 6 · 215 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
2026-09-14 22:38:34	2026-08	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203638-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203638-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203638-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203638-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203638-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203638-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203638-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203638-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203638-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203638-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203638-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203638-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-005	AB	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	5 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
1049621	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
4e9e945d-5ffc-48de-99fa-3fb36c5bc2b9	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71335-0981-1	2024-05-31	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-2	2024-05-31	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-3	2024-05-31	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-4	2024-05-31	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-5	2024-05-31	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-6	2024-05-31	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-7	2024-05-31	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-8	2024-05-31	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-9	2024-05-31	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-1	2024-01-30	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-2	2024-01-30	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-3	2024-01-30	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-4	2024-01-30	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-5	2024-01-30	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-6	2024-01-30	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-7	2024-01-30	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-8	2024-01-30	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-9	2024-01-30	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0981-0	Oxycodone Hydrochloride	15 in 1 BOTTLE	TABLET	15	101
71335-0981-1	Oxycodone Hydrochloride	30 in 1 BOTTLE	TABLET	30	101
71335-0981-2	Oxycodone Hydrochloride	60 in 1 BOTTLE	TABLET	60	101
71335-0981-3	Oxycodone Hydrochloride	90 in 1 BOTTLE	TABLET	90	101
71335-0981-4	Oxycodone Hydrochloride	56 in 1 BOTTLE	TABLET	56	101
71335-0981-5	Oxycodone Hydrochloride	100 in 1 BOTTLE	TABLET	100	101
71335-0981-6	Oxycodone Hydrochloride	120 in 1 BOTTLE	TABLET	120	101
71335-0981-7	Oxycodone Hydrochloride	50 in 1 BOTTLE	TABLET	50	101
71335-0981-8	Oxycodone Hydrochloride	40 in 1 BOTTLE	TABLET	40	101
71335-0981-9	Oxycodone Hydrochloride	20 in 1 BOTTLE	TABLET	20	101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0981-1	EA - Each	71335-0981	42de481b-a53a-4e06-9173-ce440317be68	1	2020-09-14
71335-0981-2	EA - Each	71335-0981	5636f1cb-9e4b-45e7-bb4a-30d281825b56	1	2020-09-14
71335-0981-3	EA - Each	71335-0981	9498c3ba-949d-4465-ad48-835e91272e68	1	2020-09-14
71335-0981-9	EA - Each	71335-0981	a350b85c-fcaa-498b-b8f0-ce7454f166c8	1	2025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0981	OXYCODONE HYDROCHLORIDE (OXYCODONE) TABLET [BRYANT RANCH PREPACK]	101	Current NDC, Legacy NDC, 10 package rows	20240601_4e9e945d-5ffc-48de-99fa-3fb36c5bc2b9.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone Hydrochloride	OXYCODONE	Major Pharmaceuticals	6b6db42b-9821-4aa6-8566-297037d84079	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE	Amneal Pharmaceuticals LLC	094b64b3-cd32-4de5-afb6-ea00d9caad74	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE	Redpharm Drug	525001a6-68d8-7ef7-e063-6294a90abc5f	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Precision Dose, Inc.	f849c7cc-fa85-47eb-be30-1be137913bf9	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	b2510d72-bf63-4c9d-ac5e-7bacd993fa10	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	232d44d2-3924-4d35-873c-d2aef75e9a41	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	d248ceba-9492-4348-aa07-31c9c73a3620	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	bc7fdf7e-ad4e-4a04-b35c-2233cc7e5f15	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	4e9e945d-5ffc-48de-99fa-3fb36c5bc2b9	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638 ndc (product): 71335-0981
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	9da42120-0214-45cb-bb98-9a7739e72d43	2024-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE	124-90-3	OXYCODONE HYDROCHLORIDE
CD35PMG570	OXYCODONE	76-42-6	Oxycodone

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049621	oxyCODONE HCl 5 MG Oral Tablet	PSN	4e9e945d-5ffc-48de-99fa-3fb36c5bc2b9	101
1049621	oxycodone hydrochloride 5 MG Oral Tablet	SCD	4e9e945d-5ffc-48de-99fa-3fb36c5bc2b9	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0981-0	71335098100	15 TABLET in 1 BOTTLE (71335-0981-0)	15 tablet	2024-05-30		No	No	Current
71335-0981-1	71335098101	30 TABLET in 1 BOTTLE (71335-0981-1)	30 tablet	2018-11-29	0000-00-00	No	No	Current
71335-0981-2	71335098102	60 TABLET in 1 BOTTLE (71335-0981-2)	60 tablet	2018-11-08	0000-00-00	No	No	Current
71335-0981-3	71335098103	90 TABLET in 1 BOTTLE (71335-0981-3)	90 tablet	2018-11-30	0000-00-00	No	No	Current
71335-0981-4	71335098104	56 TABLET in 1 BOTTLE (71335-0981-4)	56 tablet	2024-05-30	0000-00-00	No	No	Current
71335-0981-5	71335098105	100 TABLET in 1 BOTTLE (71335-0981-5)	100 tablet	2024-05-30	0000-00-00	No	No	Current
71335-0981-6	71335098106	120 TABLET in 1 BOTTLE (71335-0981-6)	120 tablet	2024-05-30	0000-00-00	No	No	Current
71335-0981-7	71335098107	50 TABLET in 1 BOTTLE (71335-0981-7)	50 tablet	2024-05-30	0000-00-00	No	No	Current
71335-0981-8	71335098108	40 TABLET in 1 BOTTLE (71335-0981-8)	40 tablet	2024-05-30	0000-00-00	No	No	Current
71335-0981-9	71335098109	20 TABLET in 1 BOTTLE (71335-0981-9)	20 tablet	2018-10-29	0000-00-00	No	No	Current