TAPENTADOL

Product NDC: 0054-0939
11-digit product format: 000540939
Labeler code: 0054
Product ID: 0054-0939_7fef46e2-c049-44d8-962f-fdd233dad041
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tapentadol Hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: NDA200533
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2025-12-15
Substance: TAPENTADOL HYDROCHLORIDE
Active strength: 200 mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
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	RLD / RS	Approval date
N200533-001	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25
N200533-002	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25
N200533-003	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25
N200533-004	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25
N200533-005	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25

Orange Book patents#

Current patent rows page 1 of 1 · 25 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N200533-001	11344512	2028-04-21	U-3391		2022-06-29
N200533-001	11344512	2028-04-21	U-3392		2022-06-29
N200533-001	8536130	2028-09-22	U-1276
N200533-001	11344512*PED	2028-10-21		Pediatric extension
N200533-001	8536130*PED	2029-03-22		Pediatric extension
N200533-002	11344512	2028-04-21	U-3391		2022-06-29
N200533-002	11344512	2028-04-21	U-3392		2022-06-29
N200533-002	8536130	2028-09-22	U-1276
N200533-002	11344512*PED	2028-10-21		Pediatric extension
N200533-002	8536130*PED	2029-03-22		Pediatric extension
N200533-003	11344512	2028-04-21	U-3391		2022-06-29
N200533-003	11344512	2028-04-21	U-3392		2022-06-29
N200533-003	8536130	2028-09-22	U-1276
N200533-003	11344512*PED	2028-10-21		Pediatric extension
N200533-003	8536130*PED	2029-03-22		Pediatric extension
N200533-004	11344512	2028-04-21	U-3391		2022-06-29
N200533-004	11344512	2028-04-21	U-3392		2022-06-29
N200533-004	8536130	2028-09-22	U-1276
N200533-004	11344512*PED	2028-10-21		Pediatric extension
N200533-004	8536130*PED	2029-03-22		Pediatric extension
N200533-005	11344512	2028-04-21	U-3391		2022-06-29
N200533-005	11344512	2028-04-21	U-3392		2022-06-29
N200533-005	8536130	2028-09-22	U-1276
N200533-005	11344512*PED	2028-10-21		Pediatric extension
N200533-005	8536130*PED	2029-03-22		Pediatric extension

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 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 50 · 1,980 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N200533-001	11344512	2028-04-21	U-3391		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-001	11344512	2028-04-21	U-3392		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-001	8536130	2028-09-22	U-1276			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-001	11344512*PED	2028-10-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-001	8536130*PED	2029-03-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-002	11344512	2028-04-21	U-3392		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-002	11344512	2028-04-21	U-3391		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-002	8536130	2028-09-22	U-1276			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-002	11344512*PED	2028-10-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-002	8536130*PED	2029-03-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-003	11344512	2028-04-21	U-3392		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-003	11344512	2028-04-21	U-3391		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-003	8536130	2028-09-22	U-1276			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-003	11344512*PED	2028-10-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-003	8536130*PED	2029-03-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-004	11344512	2028-04-21	U-3392		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-004	11344512	2028-04-21	U-3391		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-004	8536130	2028-09-22	U-1276			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-004	11344512*PED	2028-10-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-004	8536130*PED	2029-03-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-005	11344512	2028-04-21	U-3392		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-005	11344512	2028-04-21	U-3391		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-005	8536130	2028-09-22	U-1276			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-005	11344512*PED	2028-10-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-005	8536130*PED	2029-03-22		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	7994364	2025-06-27	U-1276	Drug substance, Drug product	2011-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	7994364	2025-06-27	U-1178	Drug substance, Drug product	2011-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	7994364*PED	2025-12-27		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	11344512	2028-04-21	U-3391		2022-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	11344512	2028-04-21	U-3392		2022-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	8536130	2028-09-22	U-1276			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	11344512*PED	2028-10-21		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	8536130*PED	2029-03-22		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	7994364	2025-06-27	U-1178	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	7994364	2025-06-27	U-1276	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	7994364*PED	2025-12-27		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	11344512	2028-04-21	U-3392		2022-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	11344512	2028-04-21	U-3391		2022-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	8536130	2028-09-22	U-1276			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	11344512*PED	2028-10-21		Pediatric extension		`31067a03dcf5…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TAPENTADOL HYDROCHLORIDE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
71204KII53	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1148797	Internal RxNorm lookup
1148800	Internal RxNorm lookup
1148803	Internal RxNorm lookup
1148807	Internal RxNorm lookup
1148809	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
38de863e-56ff-4c43-9ab8-9b3e1ba82858	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
279f6ab2-ad0d-a4be-abc3-377fa3441fa2	Product name	1	20140508
41331914-7851-9471-14c3-fea0cf65689e	Product name	1	20140508
7142c439-ef45-40fb-d30b-dd20e4faf1c1	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0054-0939-21	TAPENTADOL	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0939-21	EA - Each	0054-0939	b77c15cf-2074-43cc-b726-67b8591829dd	1	2026-04-20

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
TAPENTADOL	TAPENTADOL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	38de863e-56ff-4c43-9ab8-9b3e1ba82858	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 200533 application number: NDA200533 ndc (product): 0054-0939
Nucynta ER	TAPENTADOL HYDROCHLORIDE	Collegium Pharmaceutical, Inc.	c3d04d70-0155-4147-9ce4-a3b1fad4b373	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 200533 application number: NDA200533

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
71204KII53	TAPENTADOL HYDROCHLORIDE	175591-09-0	TAPENTADOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1148797	tapentadol 100 MG 12HR Extended Release Oral Tablet	PSN	38de863e-56ff-4c43-9ab8-9b3e1ba82858	3
1148800	tapentadol 150 MG 12HR Extended Release Oral Tablet	PSN	38de863e-56ff-4c43-9ab8-9b3e1ba82858	3
1148803	tapentadol 200 MG 12HR Extended Release Oral Tablet	PSN	38de863e-56ff-4c43-9ab8-9b3e1ba82858	3
1148807	tapentadol 250 MG 12HR Extended Release Oral Tablet	PSN	38de863e-56ff-4c43-9ab8-9b3e1ba82858	3
1148809	tapentadol 50 MG 12HR Extended Release Oral Tablet	PSN	38de863e-56ff-4c43-9ab8-9b3e1ba82858	3
1148797	12 HR tapentadol 100 MG Extended Release Oral Tablet	SCD	38de863e-56ff-4c43-9ab8-9b3e1ba82858	3
1148800	12 HR tapentadol 150 MG Extended Release Oral Tablet	SCD	38de863e-56ff-4c43-9ab8-9b3e1ba82858	3
1148803	12 HR tapentadol 200 MG Extended Release Oral Tablet	SCD	38de863e-56ff-4c43-9ab8-9b3e1ba82858	3
1148807	12 HR tapentadol 250 MG Extended Release Oral Tablet	SCD	38de863e-56ff-4c43-9ab8-9b3e1ba82858	3
1148809	12 HR tapentadol 50 MG Extended Release Oral Tablet	SCD	38de863e-56ff-4c43-9ab8-9b3e1ba82858	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0054-0939-21	00054093921	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0939-21)	2025-12-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TAPENTADOL	Hikma Pharmaceuticals USA Inc. \| Collegium Pharmaceutical, Inc.	2026-02-26	HUMAN PRESCRIPTION DRUG LABEL	3