Application 206627

Type: NDA
Sponsor: PURDUE PHARMA LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYSINGLA ER	HYDROCODONE BITARTRATE	TABLET, EXTENDED RELEASE;ORAL	20MG	Yes	Yes
002	HYSINGLA ER	HYDROCODONE BITARTRATE	TABLET, EXTENDED RELEASE;ORAL	30MG	Yes	No
003	HYSINGLA ER	HYDROCODONE BITARTRATE	TABLET, EXTENDED RELEASE;ORAL	40MG	Yes	No
004	HYSINGLA ER	HYDROCODONE BITARTRATE	TABLET, EXTENDED RELEASE;ORAL	60MG	Yes	No
005	HYSINGLA ER	HYDROCODONE BITARTRATE	TABLET, EXTENDED RELEASE;ORAL	80MG	Yes	No
006	HYSINGLA ER	HYDROCODONE BITARTRATE	TABLET, EXTENDED RELEASE;ORAL	100MG	Yes	No
007	HYSINGLA ER	HYDROCODONE BITARTRATE	TABLET, EXTENDED RELEASE;ORAL	120MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N206627-001	HYSINGLA ER	HYDROCODONE BITARTRATE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-11-20
N206627-002	HYSINGLA ER	HYDROCODONE BITARTRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20
N206627-003	HYSINGLA ER	HYDROCODONE BITARTRATE	40MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20
N206627-004	HYSINGLA ER	HYDROCODONE BITARTRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20
N206627-005	HYSINGLA ER	HYDROCODONE BITARTRATE	80MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20
N206627-006	HYSINGLA ER	HYDROCODONE BITARTRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20
N206627-007	HYSINGLA ER	HYDROCODONE BITARTRATE	120MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-11-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N206627-001	AB
N206627-002	AB
N206627-003	AB
N206627-004	AB
N206627-005	AB
N206627-006	AB

Orange Book patents#

Current patent rows page 1 of 2 · 133 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206627-001	11304908	2027-08-24		Drug product	2022-04-21
N206627-001	11304909	2027-08-24	U-1556		2022-04-21
N206627-001	9084816	2027-08-24		Drug product	2015-07-21
N206627-001	9095614	2027-08-24	U-1556		2015-08-04
N206627-001	9095615	2027-08-24		Drug product	2015-08-04
N206627-001	9486412	2027-08-24		Drug product	2016-11-08
N206627-001	9486413	2027-08-24		Drug product	2016-11-08
N206627-001	9492389	2027-08-24		Drug product	2016-11-16
N206627-001	9492390	2027-08-24	U-1556		2016-11-17
N206627-001	9492391	2027-08-24	U-1556		2016-11-17
N206627-001	9545380	2027-08-24	U-1556		2017-01-17
N206627-001	9763933	2027-08-24		Drug product	2017-09-19
N206627-001	9770416	2027-08-24		Drug product	2017-09-27
N206627-001	9775809	2027-08-24		Drug product	2017-10-04
N206627-001	8808740	2031-12-21	U-1556	Drug product	2014-11-21
N206627-001	9572779	2031-12-21		Drug product	2017-02-21
N206627-001	9750703	2031-12-21		Drug product	2017-09-14
N206627-001	9861584	2031-12-21		Drug product	2018-01-10
N206627-001	9872837	2031-12-21		Drug product	2018-01-23
N206627-002	11304908	2027-08-24		Drug product	2022-04-21
N206627-002	11304909	2027-08-24	U-1556		2022-04-21
N206627-002	9084816	2027-08-24		Drug product	2015-07-21
N206627-002	9095614	2027-08-24	U-1556		2015-08-04
N206627-002	9095615	2027-08-24		Drug product	2015-08-04
N206627-002	9486412	2027-08-24		Drug product	2016-11-08
N206627-002	9486413	2027-08-24		Drug product	2016-11-08
N206627-002	9492389	2027-08-24		Drug product	2016-11-16
N206627-002	9492390	2027-08-24	U-1556		2016-11-17
N206627-002	9492391	2027-08-24	U-1556		2016-11-17
N206627-002	9545380	2027-08-24	U-1556		2017-01-17
N206627-002	9763933	2027-08-24		Drug product	2017-09-19
N206627-002	9770416	2027-08-24		Drug product	2017-09-27
N206627-002	9775809	2027-08-24		Drug product	2017-10-04
N206627-002	8808740	2031-12-21	U-1556	Drug product	2014-11-21
N206627-002	9572779	2031-12-21		Drug product	2017-02-21
N206627-002	9750703	2031-12-21		Drug product	2017-09-14
N206627-002	9861584	2031-12-21		Drug product	2018-01-10
N206627-002	9872837	2031-12-21		Drug product	2018-01-23
N206627-003	11304908	2027-08-24		Drug product	2022-04-21
N206627-003	11304909	2027-08-24	U-1556		2022-04-21
N206627-003	9084816	2027-08-24		Drug product	2015-07-21
N206627-003	9095614	2027-08-24	U-1556		2015-08-04
N206627-003	9095615	2027-08-24		Drug product	2015-08-04
N206627-003	9486412	2027-08-24		Drug product	2016-11-08
N206627-003	9486413	2027-08-24		Drug product	2016-11-08
N206627-003	9492389	2027-08-24		Drug product	2016-11-16
N206627-003	9492390	2027-08-24	U-1556		2016-11-17
N206627-003	9492391	2027-08-24	U-1556		2016-11-17
N206627-003	9545380	2027-08-24	U-1556		2017-01-17
N206627-003	9763933	2027-08-24		Drug product	2017-09-19
N206627-003	9770416	2027-08-24		Drug product	2017-09-27
N206627-003	9775809	2027-08-24		Drug product	2017-10-04
N206627-003	8808740	2031-12-21	U-1556	Drug product	2014-11-21
N206627-003	9572779	2031-12-21		Drug product	2017-02-21
N206627-003	9750703	2031-12-21		Drug product	2017-09-14
N206627-003	9861584	2031-12-21		Drug product	2018-01-10
N206627-003	9872837	2031-12-21		Drug product	2018-01-23
N206627-004	11304908	2027-08-24		Drug product	2022-04-21
N206627-004	11304909	2027-08-24	U-1556		2022-04-21
N206627-004	9084816	2027-08-24		Drug product	2015-07-21
N206627-004	9095614	2027-08-24	U-1556		2015-08-04
N206627-004	9095615	2027-08-24		Drug product	2015-08-04
N206627-004	9486412	2027-08-24		Drug product	2016-11-08
N206627-004	9486413	2027-08-24		Drug product	2016-11-08
N206627-004	9492389	2027-08-24		Drug product	2016-11-16
N206627-004	9492390	2027-08-24	U-1556		2016-11-17
N206627-004	9492391	2027-08-24	U-1556		2016-11-17
N206627-004	9545380	2027-08-24	U-1556		2017-01-17
N206627-004	9763933	2027-08-24		Drug product	2017-09-19
N206627-004	9770416	2027-08-24		Drug product	2017-09-27
N206627-004	9775809	2027-08-24		Drug product	2017-10-04
N206627-004	8808740	2031-12-21	U-1556	Drug product	2014-11-21
N206627-004	9572779	2031-12-21		Drug product	2017-02-21
N206627-004	9750703	2031-12-21		Drug product	2017-09-14
N206627-004	9861584	2031-12-21		Drug product	2018-01-10
N206627-004	9872837	2031-12-21		Drug product	2018-01-23
N206627-005	11304908	2027-08-24		Drug product	2022-04-21
N206627-005	11304909	2027-08-24	U-1556		2022-04-21
N206627-005	9084816	2027-08-24		Drug product	2015-07-21
N206627-005	9095614	2027-08-24	U-1556		2015-08-04

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 8 · 294 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N206627-001	HYSINGLA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	HYSINGLA ER	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-003	HYSINGLA ER	40MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-004	HYSINGLA ER	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-005	HYSINGLA ER	80MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-006	HYSINGLA ER	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-007	HYSINGLA ER	120MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206627-001	HYSINGLA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	HYSINGLA ER	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-003	HYSINGLA ER	40MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-004	HYSINGLA ER	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-005	HYSINGLA ER	80MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-006	HYSINGLA ER	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-007	HYSINGLA ER	120MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206627-001	HYSINGLA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206627-002	HYSINGLA ER	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206627-003	HYSINGLA ER	40MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206627-004	HYSINGLA ER	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206627-005	HYSINGLA ER	80MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206627-006	HYSINGLA ER	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206627-007	HYSINGLA ER	120MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206627-001	HYSINGLA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206627-002	HYSINGLA ER	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206627-003	HYSINGLA ER	40MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206627-004	HYSINGLA ER	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206627-005	HYSINGLA ER	80MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206627-006	HYSINGLA ER	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206627-007	HYSINGLA ER	120MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206627-001	HYSINGLA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206627-002	HYSINGLA ER	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206627-003	HYSINGLA ER	40MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206627-004	HYSINGLA ER	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206627-005	HYSINGLA ER	80MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206627-006	HYSINGLA ER	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206627-007	HYSINGLA ER	120MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206627-001	HYSINGLA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206627-002	HYSINGLA ER	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206627-003	HYSINGLA ER	40MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206627-004	HYSINGLA ER	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206627-005	HYSINGLA ER	80MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 237 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N206627-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206627-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206627-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206627-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206627-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206627-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206627-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206627-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206627-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206627-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206627-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206627-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206627-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206627-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206627-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206627-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206627-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206627-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206627-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206627-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206627-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206627-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206627-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206627-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206627-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206627-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206627-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206627-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206627-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206627-004	AB	1	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 177 · 7,052 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N206627-001	11304908	2027-08-24		Drug product	2022-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-001	11304909	2027-08-24	U-1556		2022-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-001	9084816	2027-08-24		Drug product	2015-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-001	9095614	2027-08-24	U-1556		2015-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-001	9095615	2027-08-24		Drug product	2015-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-001	9486412	2027-08-24		Drug product	2016-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-001	9486413	2027-08-24		Drug product	2016-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-001	9492389	2027-08-24		Drug product	2016-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-001	9492390	2027-08-24	U-1556		2016-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-001	9492391	2027-08-24	U-1556		2016-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-001	9545380	2027-08-24	U-1556		2017-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-001	9763933	2027-08-24		Drug product	2017-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-001	9770416	2027-08-24		Drug product	2017-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-001	9775809	2027-08-24		Drug product	2017-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-001	8808740	2031-12-21	U-1556	Drug product	2014-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-001	9572779	2031-12-21		Drug product	2017-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-001	9750703	2031-12-21		Drug product	2017-09-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-001	9861584	2031-12-21		Drug product	2018-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-001	9872837	2031-12-21		Drug product	2018-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	11304908	2027-08-24		Drug product	2022-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	11304909	2027-08-24	U-1556		2022-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	9084816	2027-08-24		Drug product	2015-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	9095614	2027-08-24	U-1556		2015-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	9095615	2027-08-24		Drug product	2015-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	9486412	2027-08-24		Drug product	2016-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	9486413	2027-08-24		Drug product	2016-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	9492389	2027-08-24		Drug product	2016-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	9492390	2027-08-24	U-1556		2016-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	9492391	2027-08-24	U-1556		2016-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	9545380	2027-08-24	U-1556		2017-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	9763933	2027-08-24		Drug product	2017-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	9770416	2027-08-24		Drug product	2017-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	9775809	2027-08-24		Drug product	2017-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	8808740	2031-12-21	U-1556	Drug product	2014-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	9572779	2031-12-21		Drug product	2017-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	9750703	2031-12-21		Drug product	2017-09-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	9861584	2031-12-21		Drug product	2018-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-002	9872837	2031-12-21		Drug product	2018-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-003	11304908	2027-08-24		Drug product	2022-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206627-003	11304909	2027-08-24	U-1556		2022-04-21	`caaa826d4ba7…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hysingla ER	HYDROCODONE BITARTRATE	Knoa Pharma LLC	b7d23ac2-e776-9f62-3290-c64c2d6eb353	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 206627 application number: NDA206627 ndc (product): 59011-271 ndc (product): 59011-273 ndc (product): 59011-274 ndc (product): 59011-276 ndc (product): 59011-272 ndc (product): 59011-275

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59011-271	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-271	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-271	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-271	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-272	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-272	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-272	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-272	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-273	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-273	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-273	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-273	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-274	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-274	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-274	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-274	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-275	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-275	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-275	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-275	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-276	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-276	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-276	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-276	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-277	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-277	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-277	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current
59011-277	Hysingla ER	hydrocodone bitartrate	Purdue Pharma LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84579	SUPPL	2025-12-29
80097	SUPPL	2024-11-04
77077	SUPPL	2023-12-19
77005	SUPPL	2023-12-19
76959	SUPPL	2023-12-18
66653	SUPPL	2021-03-08
66652	SUPPL	2021-03-08
66613	SUPPL	2021-03-08
60856	SUPPL	2019-11-15
60851	SUPPL	2019-11-15
60504	SUPPL	2019-10-09
60503	SUPPL	2019-10-09
60370	SUPPL	2019-10-08
55687	SUPPL	2018-10-01
55686	SUPPL	2018-10-01
55539	SUPPL	2018-09-21
55538	SUPPL	2018-09-21
48588	SUPPL	2017-05-31
46443	SUPPL	2016-12-21
46319	SUPPL	2016-12-20
45452	SUPPL	2016-10-03
32822	SUPPL	2016-04-22
24129	ORIG	2015-11-04
32821	SUPPL	2015-07-08
43525	ORIG	2015-04-07
24521	ORIG	2015-04-07
24130	ORIG	2014-12-11
44433	ORIG	2014-11-20
43559	ORIG	2014-11-20
40563	ORIG	2014-11-20
32820	ORIG	2014-11-20
84630	SUPPL