Prolate

Product NDC: 72245-648
11-digit product format: 722450648
Labeler code: 72245
Product ID: 72245-648_4bbacb0d-57c5-93e7-e063-6394a90a050b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxycodone hydrochloride and acetaminophen
Dosage form: SOLUTION
Route: ORAL
Labeler: Forte Bio-Pharma LLC
Application: ANDA202142
Marketing category: ANDA
Marketing start: 2020-03-01
Substance: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength: 300; 10 mg/5mL; mg/5mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202142-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	300MG/5ML;10MG/5ML	SOLUTION / ORAL			2018-11-27

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202142-001	OXYCODONE AND ACETAMINOPHEN	300MG/5ML;10MG/5ML	SOLUTION / ORAL	2018-11-27	`e64feba35796…`

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/5mL
ACETAMINOPHEN	10 mg/5mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2105822	Internal RxNorm lookup
2281851	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
9d75ad3b-bc9b-0c22-e053-2a95a90ac71e	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
72245-648-12	Prolate	120 mL in 1 BOTTLE, PLASTIC	SOLUTION	120		7
72245-648-50	Prolate	500 mL in 1 BOTTLE, PLASTIC	SOLUTION	500		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72245-648-12	ML - Milliliter	72245-648	945284ea-dff0-4169-979d-ee908805e043	1	2021-04-08
72245-648-50	ML - Milliliter	72245-648	3d5e0c17-3eb9-41d6-a3a1-0c7f653369c0	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72245-648	PROLATE (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) SOLUTION [FORTE BIO-PHARMA LLC]	5	Current NDC, Legacy NDC, 2 package rows	20240110_9d75ad3b-bc9b-0c22-e053-2a95a90ac71e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prolate	OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN	Forte Bio-Pharma LLC	9d75ad3b-bc9b-0c22-e053-2a95a90ac71e	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202142 application number: ANDA202142 ndc (product): 72245-648
oxycodone hydrochloride and acetaminophen	OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN	FH2 Pharma LLC	96b0067e-aabe-df4f-e053-2995a90a4a86	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202142 application number: ANDA202142

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
2105822	oxyCODONE HCl 10 MG / acetaminophen 300 MG in 5 mL Oral Solution	PSN	9d75ad3b-bc9b-0c22-e053-2a95a90ac71e	7
2281851	Prolate 10 MG / 300 MG in 5 mL Oral Solution	PSN	9d75ad3b-bc9b-0c22-e053-2a95a90ac71e	7
2281851	acetaminophen 60 MG/ML / oxycodone hydrochloride 2 MG/ML Oral Solution [Prolate]	SBD	9d75ad3b-bc9b-0c22-e053-2a95a90ac71e	7
2105822	acetaminophen 60 MG/ML / oxycodone hydrochloride 2 MG/ML Oral Solution	SCD	9d75ad3b-bc9b-0c22-e053-2a95a90ac71e	7
2105822	APAP 60 MG/ML / Oxycodone Hydrochloride 2 MG/ML Oral Solution	SY	9d75ad3b-bc9b-0c22-e053-2a95a90ac71e	7
2281851	APAP 60 MG/ML / Oxycodone Hydrochloride 2 MG/ML Oral Solution [Prolate]	SY	9d75ad3b-bc9b-0c22-e053-2a95a90ac71e	7
2105822	oxycodone HCl 10 MG / acetaminophen 300 MG per 5 ML Oral Solution	SY	9d75ad3b-bc9b-0c22-e053-2a95a90ac71e	7
2105822	oxycodone HCl 2 MG/ML / acetaminophen 60 MG/ML Oral Solution	SY	9d75ad3b-bc9b-0c22-e053-2a95a90ac71e	7
2281851	Prolate (oxycodone HCl 10 MG / acetaminophen 300 MG per 5 ML) Oral Solution	SY	9d75ad3b-bc9b-0c22-e053-2a95a90ac71e	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72245-648-12	72245064812	120 mL in 1 BOTTLE, PLASTIC (72245-648-12)	120 ml	2020-03-01	0000-00-00	No	No	Current
72245-648-50	72245064850	500 mL in 1 BOTTLE, PLASTIC (72245-648-50)	500 ml	2020-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prolate (Oxycodone Hydrochloride and Acetaminophen Oral Solution)	Forte Bio-Pharma LLC	2026-07-28	HUMAN PRESCRIPTION DRUG LABEL	8