National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2012-07-24
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 02:39:32

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
60793-433-01	EA - Each	60793-433	c7bf8cfe-2519-4012-af55-c12dfc8fee2e	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60793-433	60793-433-01

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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022321-001	EMBEDA	MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE	20MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13
N022321-002	EMBEDA	MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE	30MG;1.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13
N022321-003	EMBEDA	MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE	50MG;2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13
N022321-004	EMBEDA	MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE	60MG;2.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13
N022321-005	EMBEDA	MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE	80MG;3.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13
N022321-006	EMBEDA	MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE	100MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13

Orange Book patents#

Current patent rows page 1 of 1 · 42 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022321-001	7682633	2027-06-19	U-1510
N022321-001	7682634	2027-06-19		Drug product
N022321-001	8158156	2027-06-19	U-1510		2012-05-10
N022321-001	8846104	2027-06-19		Drug product	2014-10-28
N022321-001	8877247	2027-06-19		Drug product	2014-12-01
N022321-001	7815934	2027-12-12		Drug product	2010-10-19
N022321-001	8623418	2029-11-07	U-1640		2015-01-22
N022321-002	7682633	2027-06-19	U-1510
N022321-002	7682634	2027-06-19		Drug product
N022321-002	8158156	2027-06-19	U-1510
N022321-002	8846104	2027-06-19		Drug product	2014-10-28
N022321-002	8877247	2027-06-19		Drug product	2014-12-01
N022321-002	7815934	2027-12-12		Drug product
N022321-002	8623418	2029-11-07	U-1640		2015-01-22
N022321-003	7682633	2027-06-19	U-1510
N022321-003	7682634	2027-06-19		Drug product
N022321-003	8158156	2027-06-19	U-1510
N022321-003	8846104	2027-06-19		Drug product	2014-10-28
N022321-003	8877247	2027-06-19		Drug product	2014-12-01
N022321-003	7815934	2027-12-12		Drug product
N022321-003	8623418	2029-11-07	U-1640		2015-01-22
N022321-004	7682633	2027-06-19	U-1510
N022321-004	7682634	2027-06-19		Drug product
N022321-004	8158156	2027-06-19	U-1510
N022321-004	8846104	2027-06-19		Drug product	2014-10-28
N022321-004	8877247	2027-06-19		Drug product	2014-12-01
N022321-004	7815934	2027-12-12		Drug product
N022321-004	8623418	2029-11-07	U-1640		2015-01-22
N022321-005	7682633	2027-06-19	U-1510
N022321-005	7682634	2027-06-19		Drug product
N022321-005	8158156	2027-06-19	U-1510
N022321-005	8846104	2027-06-19		Drug product	2014-10-28
N022321-005	8877247	2027-06-19		Drug product	2014-12-01
N022321-005	7815934	2027-12-12		Drug product
N022321-005	8623418	2029-11-07	U-1640		2015-01-22
N022321-006	7682633	2027-06-19	U-1510
N022321-006	7682634	2027-06-19		Drug product
N022321-006	8158156	2027-06-19	U-1510
N022321-006	8846104	2027-06-19		Drug product	2014-10-28
N022321-006	8877247	2027-06-19		Drug product	2014-12-01
N022321-006	7815934	2027-12-12		Drug product
N022321-006	8623418	2029-11-07	U-1640		2015-01-22

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 7 · 258 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	N022321-001	EMBEDA	20MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-002	EMBEDA	30MG;1.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-003	EMBEDA	50MG;2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-004	EMBEDA	60MG;2.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-005	EMBEDA	80MG;3.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-006	EMBEDA	100MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022321-001	EMBEDA	20MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022321-002	EMBEDA	30MG;1.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022321-003	EMBEDA	50MG;2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022321-004	EMBEDA	60MG;2.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022321-005	EMBEDA	80MG;3.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022321-006	EMBEDA	100MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022321-001	EMBEDA	20MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022321-002	EMBEDA	30MG;1.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022321-003	EMBEDA	50MG;2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022321-004	EMBEDA	60MG;2.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022321-005	EMBEDA	80MG;3.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022321-006	EMBEDA	100MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022321-001	EMBEDA	20MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022321-002	EMBEDA	30MG;1.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022321-003	EMBEDA	50MG;2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022321-004	EMBEDA	60MG;2.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022321-005	EMBEDA	80MG;3.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022321-006	EMBEDA	100MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022321-001	EMBEDA	20MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022321-002	EMBEDA	30MG;1.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022321-003	EMBEDA	50MG;2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022321-004	EMBEDA	60MG;2.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022321-005	EMBEDA	80MG;3.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022321-006	EMBEDA	100MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022321-001	EMBEDA	20MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022321-002	EMBEDA	30MG;1.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022321-003	EMBEDA	50MG;2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022321-004	EMBEDA	60MG;2.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022321-005	EMBEDA	80MG;3.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022321-006	EMBEDA	100MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022321-001	EMBEDA	20MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022321-002	EMBEDA	30MG;1.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022321-003	EMBEDA	50MG;2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022321-004	EMBEDA	60MG;2.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2009-08-13	`b8a1b40f171c…`

Observed Orange Book patent history#

Patent history page 1 of 57 · 2,274 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	N022321-001	7682633	2027-06-19	U-1510			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-001	7682634	2027-06-19		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-001	8158156	2027-06-19	U-1510		2012-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-001	8846104	2027-06-19		Drug product	2014-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-001	8877247	2027-06-19		Drug product	2014-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-001	7815934	2027-12-12		Drug product	2010-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-001	8623418	2029-11-07	U-1640		2015-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-002	7682633	2027-06-19	U-1510			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-002	7682634	2027-06-19		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-002	8158156	2027-06-19	U-1510			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-002	8846104	2027-06-19		Drug product	2014-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-002	8877247	2027-06-19		Drug product	2014-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-002	7815934	2027-12-12		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-002	8623418	2029-11-07	U-1640		2015-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-003	7682633	2027-06-19	U-1510			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-003	7682634	2027-06-19		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-003	8158156	2027-06-19	U-1510			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-003	8846104	2027-06-19		Drug product	2014-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-003	8877247	2027-06-19		Drug product	2014-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-003	7815934	2027-12-12		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-003	8623418	2029-11-07	U-1640		2015-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-004	7682633	2027-06-19	U-1510			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-004	7682634	2027-06-19		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-004	8158156	2027-06-19	U-1510			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-004	8846104	2027-06-19		Drug product	2014-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-004	8877247	2027-06-19		Drug product	2014-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-004	7815934	2027-12-12		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-004	8623418	2029-11-07	U-1640		2015-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-005	7682633	2027-06-19	U-1510			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-005	7682634	2027-06-19		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-005	8158156	2027-06-19	U-1510			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-005	8846104	2027-06-19		Drug product	2014-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-005	8877247	2027-06-19		Drug product	2014-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-005	7815934	2027-12-12		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-005	8623418	2029-11-07	U-1640		2015-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-006	7682633	2027-06-19	U-1510			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-006	7682634	2027-06-19		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-006	8158156	2027-06-19	U-1510			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-006	8846104	2027-06-19		Drug product	2014-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022321-006	8877247	2027-06-19		Drug product	2014-12-01	`84e616aacf4f…`

Reported adverse events (FAERS/openFDA)#

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