National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2013-02-13
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 03:16:20

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
35356-820-60	EA - Each	35356-820	1be3210a-fa80-4ea7-affa-e512aff530f6	1	2013-02-13

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
35356-820	35356-820-60

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS	Approval date
N201655-001	OPANA ER	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09
N201655-002	OPANA ER	OXYMORPHONE HYDROCHLORIDE	7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09
N201655-003	OPANA ER	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09
N201655-004	OPANA ER	OXYMORPHONE HYDROCHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09
N201655-005	OPANA ER	OXYMORPHONE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09
N201655-006	OPANA ER	OXYMORPHONE HYDROCHLORIDE	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09
N201655-007	OPANA ER	OXYMORPHONE HYDROCHLORIDE	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201655-001	8808737	2027-06-21	U-1598		2014-11-07
N201655-001	7851482	2029-07-10		Drug substance	2012-03-22
N201655-001	8871779	2029-11-22		Drug substance	2014-11-07
N201655-002	8808737	2027-06-21	U-1598		2014-11-07
N201655-002	7851482	2029-07-10		Drug substance
N201655-002	8871779	2029-11-22		Drug substance	2014-11-07
N201655-003	8808737	2027-06-21	U-1598		2014-11-07
N201655-003	7851482	2029-07-10		Drug substance
N201655-003	8871779	2029-11-22		Drug substance	2014-11-07
N201655-004	8808737	2027-06-21	U-1598		2014-11-07
N201655-004	7851482	2029-07-10		Drug substance
N201655-004	8871779	2029-11-22		Drug substance	2014-11-07
N201655-005	8808737	2027-06-21	U-1598		2014-11-07
N201655-005	7851482	2029-07-10		Drug substance
N201655-005	8871779	2029-11-22		Drug substance	2014-11-07
N201655-006	8808737	2027-06-21	U-1598		2014-11-07
N201655-006	7851482	2029-07-10		Drug substance
N201655-006	8871779	2029-11-22		Drug substance	2014-11-07
N201655-007	8808737	2027-06-21	U-1598		2014-11-07
N201655-007	7851482	2029-07-10		Drug substance
N201655-007	8871779	2029-11-22		Drug substance	2014-11-07

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 · 301 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N201655-001	OPANA ER	5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-002	OPANA ER	7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-003	OPANA ER	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-004	OPANA ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-005	OPANA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-006	OPANA ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-007	OPANA ER	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201655-001	OPANA ER	5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-002	OPANA ER	7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-003	OPANA ER	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-004	OPANA ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-005	OPANA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-006	OPANA ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-007	OPANA ER	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201655-001	OPANA ER	5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-002	OPANA ER	7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-003	OPANA ER	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-004	OPANA ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-005	OPANA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-006	OPANA ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201655-007	OPANA ER	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-001	OPANA ER	5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-002	OPANA ER	7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-003	OPANA ER	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-004	OPANA ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-005	OPANA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-006	OPANA ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201655-007	OPANA ER	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201655-001	OPANA ER	5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201655-002	OPANA ER	7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201655-003	OPANA ER	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201655-004	OPANA ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201655-005	OPANA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201655-006	OPANA ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201655-007	OPANA ER	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201655-001	OPANA ER	5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201655-002	OPANA ER	7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201655-003	OPANA ER	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201655-004	OPANA ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201655-005	OPANA ER	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-09	`fd3edfee7708…`

Observed Orange Book patent history#

Patent history page 1 of 53 · 2,093 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N201655-001	8808737	2027-06-21	U-1598		2014-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-001	7851482	2029-07-10		Drug substance	2012-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-001	8871779	2029-11-22		Drug substance	2014-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-002	8808737	2027-06-21	U-1598		2014-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-002	7851482	2029-07-10		Drug substance		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-002	8871779	2029-11-22		Drug substance	2014-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-003	8808737	2027-06-21	U-1598		2014-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-003	7851482	2029-07-10		Drug substance		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-003	8871779	2029-11-22		Drug substance	2014-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-004	8808737	2027-06-21	U-1598		2014-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-004	7851482	2029-07-10		Drug substance		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-004	8871779	2029-11-22		Drug substance	2014-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-005	8808737	2027-06-21	U-1598		2014-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-005	7851482	2029-07-10		Drug substance		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-005	8871779	2029-11-22		Drug substance	2014-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-006	8808737	2027-06-21	U-1598		2014-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-006	7851482	2029-07-10		Drug substance		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-006	8871779	2029-11-22		Drug substance	2014-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-007	8808737	2027-06-21	U-1598		2014-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-007	7851482	2029-07-10		Drug substance		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201655-007	8871779	2029-11-22		Drug substance	2014-11-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201655-001	8808737	2027-06-21	U-1598		2014-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-001	7851482	2029-07-10		Drug substance	2012-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-001	8871779	2029-11-22		Drug substance	2014-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-002	8808737	2027-06-21	U-1598		2014-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-002	7851482	2029-07-10		Drug substance		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-002	8871779	2029-11-22		Drug substance	2014-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-003	8808737	2027-06-21	U-1598		2014-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-003	7851482	2029-07-10		Drug substance		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-003	8871779	2029-11-22		Drug substance	2014-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-004	8808737	2027-06-21	U-1598		2014-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-004	7851482	2029-07-10		Drug substance		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-004	8871779	2029-11-22		Drug substance	2014-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-005	8808737	2027-06-21	U-1598		2014-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-005	7851482	2029-07-10		Drug substance		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-005	8871779	2029-11-22		Drug substance	2014-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-006	8808737	2027-06-21	U-1598		2014-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-006	7851482	2029-07-10		Drug substance		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-006	8871779	2029-11-22		Drug substance	2014-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201655-007	8808737	2027-06-21	U-1598		2014-11-07	`caaa826d4ba7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.