Prolate

Product NDC: 72245-681
11-digit product format: 722450681
Labeler code: 72245
Product ID: 72245-681_4c0a051e-78a7-de5f-e063-6294a90a90c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxycodone and acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Forte Bio-Pharma LLC
Application: ANDA040608
Marketing category: ANDA
Marketing start: 2020-02-17
Substance: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength: 300; 5 mg/1; 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 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
A040608-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30
A040608-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	300MG;5MG	TABLET / ORAL	RS	2005-12-30
A040608-003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30
A040608-004	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	300MG;10MG	TABLET / ORAL	RS	2005-12-30

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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`d8e5a09893c0…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYCODONE HYDROCHLORIDE	300 mg/1
ACETAMINOPHEN	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C1ENJ2TE6C	Internal UNII lookup
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1014599	Internal RxNorm lookup
1014615	Internal RxNorm lookup
1014632	Internal RxNorm lookup
2279510	Internal RxNorm lookup
2279512	Internal RxNorm lookup
2279514	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
9cbbfa94-37b9-9652-e053-2995a90a736b	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
72245-681-03	Prolate	30 in 1 BOTTLE, PLASTIC	TABLET	30		8
72245-681-10	Prolate	100 in 1 BOTTLE, PLASTIC	TABLET	100		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72245-681-03	EA - Each	72245-681	d0f64049-ca74-4112-8914-d23ceb9df733	1	2020-03-10
72245-681-10	EA - Each	72245-681	b699d5fc-6816-46dc-b098-9cec46c2704b	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72245-681	PROLATE (OXYCODONE AND ACETAMINOPHEN) TABLET [FORTE BIO-PHARMA LLC]	7	Current NDC, Legacy NDC, 2 package rows	20241109_9cbbfa94-37b9-9652-e053-2995a90a736b.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nalocet	OXYCODONE AND ACETAMINOPHEN	Forte Bio-Pharma LLC	f5f7dfca-a5c7-4445-8a5e-9ec62f33f5be	2026-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040608 application number: ANDA040608
oxycodone and acetaminophen	OXYCODONE AND ACETAMINOPHEN	FH2 Pharma LLC	88d97caf-bcf5-3cde-e053-2995a90acf4a	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040608 application number: ANDA040608
Prolate	OXYCODONE AND ACETAMINOPHEN	Forte Bio-Pharma LLC	9cbbfa94-37b9-9652-e053-2995a90a736b	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040608 application number: ANDA040608 ndc (product): 72245-681

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1014599	oxyCODONE HCl 10 MG / acetaminophen 300 MG Oral Tablet	PSN	9cbbfa94-37b9-9652-e053-2995a90a736b	8
1014615	oxyCODONE HCl 5 MG / acetaminophen 300 MG Oral Tablet	PSN	9cbbfa94-37b9-9652-e053-2995a90a736b	8
1014632	oxyCODONE HCl 7.5 MG / acetaminophen 300 MG Oral Tablet	PSN	9cbbfa94-37b9-9652-e053-2995a90a736b	8
2279510	Prolate 10 / 300 Oral Tablet	PSN	9cbbfa94-37b9-9652-e053-2995a90a736b	8
2279512	Prolate 5 / 300 Oral Tablet	PSN	9cbbfa94-37b9-9652-e053-2995a90a736b	8
2279514	Prolate 7.5 / 300 Oral Tablet	PSN	9cbbfa94-37b9-9652-e053-2995a90a736b	8
2279510	acetaminophen 300 MG / oxycodone hydrochloride 10 MG Oral Tablet [Prolate]	SBD	9cbbfa94-37b9-9652-e053-2995a90a736b	8
2279512	acetaminophen 300 MG / oxycodone hydrochloride 5 MG Oral Tablet [Prolate]	SBD	9cbbfa94-37b9-9652-e053-2995a90a736b	8
2279514	acetaminophen 300 MG / oxycodone hydrochloride 7.5 MG Oral Tablet [Prolate]	SBD	9cbbfa94-37b9-9652-e053-2995a90a736b	8
1014599	acetaminophen 300 MG / oxycodone hydrochloride 10 MG Oral Tablet	SCD	9cbbfa94-37b9-9652-e053-2995a90a736b	8
1014615	acetaminophen 300 MG / oxycodone hydrochloride 5 MG Oral Tablet	SCD	9cbbfa94-37b9-9652-e053-2995a90a736b	8
1014632	acetaminophen 300 MG / oxycodone hydrochloride 7.5 MG Oral Tablet	SCD	9cbbfa94-37b9-9652-e053-2995a90a736b	8
1014615	APAP 300 MG / oxycodone 5 MG Oral Tablet	SY	9cbbfa94-37b9-9652-e053-2995a90a736b	8
1014599	APAP 300 MG / oxycodone hydrochloride 10 MG Oral Tablet	SY	9cbbfa94-37b9-9652-e053-2995a90a736b	8
2279510	APAP 300 MG / Oxycodone Hydrochloride 10 MG Oral Tablet [Prolate]	SY	9cbbfa94-37b9-9652-e053-2995a90a736b	8
1014615	APAP 300 MG / Oxycodone Hydrochloride 5 MG Oral Tablet	SY	9cbbfa94-37b9-9652-e053-2995a90a736b	8
2279512	APAP 300 MG / Oxycodone Hydrochloride 5 MG Oral Tablet [Prolate]	SY	9cbbfa94-37b9-9652-e053-2995a90a736b	8
1014632	APAP 300 MG / Oxycodone Hydrochloride 7.5 MG Oral Tablet	SY	9cbbfa94-37b9-9652-e053-2995a90a736b	8
2279514	APAP 300 MG / Oxycodone Hydrochloride 7.5 MG Oral Tablet [Prolate]	SY	9cbbfa94-37b9-9652-e053-2995a90a736b	8
2279510	Prolate (acetaminophen 300 MG / oxycodone HCl 10 MG) Oral Tablet	SY	9cbbfa94-37b9-9652-e053-2995a90a736b	8
2279512	Prolate (acetaminophen 300 MG / oxycodone HCl 5 MG) Oral Tablet	SY	9cbbfa94-37b9-9652-e053-2995a90a736b	8
2279514	Prolate (acetaminophen 300 MG / oxycodone HCl 7.5 MG) Oral Tablet	SY	9cbbfa94-37b9-9652-e053-2995a90a736b	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72245-681-03	72245068103	30 TABLET in 1 BOTTLE, PLASTIC (72245-681-03)	30 tablet	2020-02-17	0000-00-00	No	No	Current
72245-681-10	72245068110	100 TABLET in 1 BOTTLE, PLASTIC (72245-681-10)	100 tablet	2020-02-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prolate ® (Oxycodone and Acetaminophen Tablets, USP)	Forte Bio-Pharma LLC	2026-05-19	HUMAN PRESCRIPTION DRUG LABEL	9