Hysingla ER

Product NDC: 59011-271
11-digit product format: 590110271
Labeler code: 59011
Product ID: 59011-271_a4f435c1-f825-4252-b9e2-d3a04a674ff3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocodone bitartrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Knoa Pharma LLC
Application: NDA206627
Marketing category: NDA
Marketing start: 2015-01-15
Substance: HYDROCODONE BITARTRATE
Active strength: 20 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 · 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 · 287 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
2026-02-19 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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206627-006	HYSINGLA ER	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206627-007	HYSINGLA ER	120MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206627-001	HYSINGLA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206627-002	HYSINGLA ER	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206627-003	HYSINGLA ER	40MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206627-004	HYSINGLA ER	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206627-005	HYSINGLA ER	80MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-11-20	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 231 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206627-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206627-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206627-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206627-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206627-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206627-004	AB	1	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 173 · 6,919 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	N206627-001	11304908	2027-08-24		Drug product	2022-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-001	11304909	2027-08-24	U-1556		2022-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-001	9084816	2027-08-24		Drug product	2015-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-001	9095614	2027-08-24	U-1556		2015-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-001	9095615	2027-08-24		Drug product	2015-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-001	9486412	2027-08-24		Drug product	2016-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-001	9486413	2027-08-24		Drug product	2016-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-001	9492389	2027-08-24		Drug product	2016-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-001	9492390	2027-08-24	U-1556		2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-001	9492391	2027-08-24	U-1556		2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-001	9545380	2027-08-24	U-1556		2017-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-001	9763933	2027-08-24		Drug product	2017-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-001	9770416	2027-08-24		Drug product	2017-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-001	9775809	2027-08-24		Drug product	2017-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-001	8808740	2031-12-21	U-1556	Drug product	2014-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-001	9572779	2031-12-21		Drug product	2017-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-001	9750703	2031-12-21		Drug product	2017-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-001	9861584	2031-12-21		Drug product	2018-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-001	9872837	2031-12-21		Drug product	2018-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	11304908	2027-08-24		Drug product	2022-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	11304909	2027-08-24	U-1556		2022-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	9084816	2027-08-24		Drug product	2015-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	9095614	2027-08-24	U-1556		2015-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	9095615	2027-08-24		Drug product	2015-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	9486412	2027-08-24		Drug product	2016-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	9486413	2027-08-24		Drug product	2016-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	9492389	2027-08-24		Drug product	2016-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	9492390	2027-08-24	U-1556		2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	9492391	2027-08-24	U-1556		2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	9545380	2027-08-24	U-1556		2017-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	9763933	2027-08-24		Drug product	2017-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	9770416	2027-08-24		Drug product	2017-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	9775809	2027-08-24		Drug product	2017-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	8808740	2031-12-21	U-1556	Drug product	2014-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	9572779	2031-12-21		Drug product	2017-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	9750703	2031-12-21		Drug product	2017-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	9861584	2031-12-21		Drug product	2018-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-002	9872837	2031-12-21		Drug product	2018-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-003	11304908	2027-08-24		Drug product	2022-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206627-003	11304909	2027-08-24	U-1556		2022-04-21	`011fe1cb6892…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCODONE BITARTRATE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NO70W886KK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1595730	Internal RxNorm lookup
1595736	Internal RxNorm lookup
1595740	Internal RxNorm lookup
1595742	Internal RxNorm lookup
1595746	Internal RxNorm lookup
1595748	Internal RxNorm lookup
1595752	Internal RxNorm lookup
1595754	Internal RxNorm lookup
1595758	Internal RxNorm lookup
1595760	Internal RxNorm lookup
1595764	Internal RxNorm lookup
1595766	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
b7d23ac2-e776-9f62-3290-c64c2d6eb353	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
53523715-c529-4d52-b9ff-1e5d76636f53	Product name	2	20210818
31b11e56-5b35-4ab6-a3a8-f0b48973dced	Product name	2	20200611
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
7855f8e3-562e-4273-8b79-0059c07a71f7	Product name	1	20170901
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
a5244f9c-cd67-0e27-d63b-65fd7e584400	Product name	2	20170504
b654f2d9-ebeb-451d-96ee-22f583344623	Product name	1	20170424
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59011-271-60	Hysingla ER	60 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	60		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59011-271-60	EA - Each	59011-271	e8844dab-fa58-4fc4-9290-fa1d911e9a15	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	3
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	3
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	3
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	3
COCHINEAL	INACTIVE INGREDIENT	TZ8Z31B35M	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	3
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59011-271	HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]	13	Current NDC, Legacy NDC, 1 package rows	20240612_b7d23ac2-e776-9f62-3290-c64c2d6eb353.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 · 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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NO70W886KK	HYDROCODONE BITARTRATE	34195-34-1	HYDROCODONE BITARTRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1595764	HYDROcodone bitartrate 100 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent	PSN	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595770	HYDROcodone bitartrate 120 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent	PSN	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595730	HYDROcodone bitartrate 20 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent	PSN	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595740	HYDROcodone bitartrate 30 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent	PSN	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595746	HYDROcodone bitartrate 40 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent	PSN	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595752	HYDROcodone bitartrate 60 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent	PSN	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595758	HYDROcodone bitartrate 80 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent	PSN	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595766	Hysingla ER 100 MG 24HR Extended Release Oral Tablet	PSN	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595772	Hysingla ER 120 MG 24HR Extended Release Oral Tablet	PSN	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595736	Hysingla ER 20 MG 24HR Extended Release Oral Tablet	PSN	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595742	Hysingla ER 30 MG 24HR Extended Release Oral Tablet	PSN	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595748	Hysingla ER 40 MG 24HR Extended Release Oral Tablet	PSN	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595754	Hysingla ER 60 MG 24HR Extended Release Oral Tablet	PSN	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595760	Hysingla ER 80 MG 24HR Extended Release Oral Tablet	PSN	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595766	Abuse-Deterrent 24 HR hydrocodone bitartrate 100 MG Extended Release Oral Tablet [Hysingla]	SBD	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595772	Abuse-Deterrent 24 HR hydrocodone bitartrate 120 MG Extended Release Oral Tablet [Hysingla]	SBD	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595736	Abuse-Deterrent 24 HR hydrocodone bitartrate 20 MG Extended Release Oral Tablet [Hysingla]	SBD	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595742	Abuse-Deterrent 24 HR hydrocodone bitartrate 30 MG Extended Release Oral Tablet [Hysingla]	SBD	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595748	Abuse-Deterrent 24 HR hydrocodone bitartrate 40 MG Extended Release Oral Tablet [Hysingla]	SBD	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595754	Abuse-Deterrent 24 HR hydrocodone bitartrate 60 MG Extended Release Oral Tablet [Hysingla]	SBD	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595760	Abuse-Deterrent 24 HR hydrocodone bitartrate 80 MG Extended Release Oral Tablet [Hysingla]	SBD	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595764	Abuse-Deterrent 24 HR hydrocodone bitartrate 100 MG Extended Release Oral Tablet	SCD	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595770	Abuse-Deterrent 24 HR hydrocodone bitartrate 120 MG Extended Release Oral Tablet	SCD	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595730	Abuse-Deterrent 24 HR hydrocodone bitartrate 20 MG Extended Release Oral Tablet	SCD	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595740	Abuse-Deterrent 24 HR hydrocodone bitartrate 30 MG Extended Release Oral Tablet	SCD	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595746	Abuse-Deterrent 24 HR hydrocodone bitartrate 40 MG Extended Release Oral Tablet	SCD	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595752	Abuse-Deterrent 24 HR hydrocodone bitartrate 60 MG Extended Release Oral Tablet	SCD	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595758	Abuse-Deterrent 24 HR hydrocodone bitartrate 80 MG Extended Release Oral Tablet	SCD	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595764	hydrocodone bitartrate 100 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent	SY	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595770	hydrocodone bitartrate 120 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent	SY	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595730	hydrocodone bitartrate 20 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent	SY	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595740	hydrocodone bitartrate 30 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent	SY	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595746	hydrocodone bitartrate 40 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent	SY	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595752	hydrocodone bitartrate 60 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent	SY	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595758	hydrocodone bitartrate 80 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent	SY	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595766	Hysingla ER 100 MG 24 HR Extended Release Oral Tablet	SY	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595772	Hysingla ER 120 MG 24 HR Extended Release Oral Tablet	SY	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595736	Hysingla ER 20 MG 24 HR Extended Release Oral Tablet	SY	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595742	Hysingla ER 30 MG 24 HR Extended Release Oral Tablet	SY	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595748	Hysingla ER 40 MG 24 HR Extended Release Oral Tablet	SY	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595754	Hysingla ER 60 MG 24 HR Extended Release Oral Tablet	SY	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16
1595760	Hysingla ER 80 MG 24 HR Extended Release Oral Tablet	SY	b7d23ac2-e776-9f62-3290-c64c2d6eb353	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59011-271-60	59011027160	60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-271-60)	2015-01-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hysingla ER	Knoa Pharma LLC \| Knoa Pharmaceuticals LLC.	2026-05-29	HUMAN PRESCRIPTION DRUG LABEL	17