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 03:29:44

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
0641-2965-41	ML - Milliliter	0641-2965	fe0e446c-cadc-4f2e-8367-85451bb94d0d	1	2013-02-13

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0641-2965	0641-2965-41

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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019386-003	BREVIBLOC	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION			1988-08-15
N019386-004	BREVIBLOC IN PLASTIC CONTAINER	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-16
N019386-005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-01-27
N019386-006	BREVIBLOC	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-02-25
N019386-007	BREVIBLOC	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION			2003-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N019386-004	AP
N019386-005	AP
N019386-006	AP

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 · 215 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
2026-09-14 22:38:34	2026-08	N019386-003	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION			1988-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019386-004	BREVIBLOC IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019386-005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019386-006	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019386-007	BREVIBLOC	20MG/ML	INJECTABLE / INJECTION			2003-05-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019386-003	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION			1988-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019386-004	BREVIBLOC IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019386-005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019386-006	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019386-007	BREVIBLOC	20MG/ML	INJECTABLE / INJECTION			2003-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019386-003	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION			1988-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019386-004	BREVIBLOC IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019386-005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019386-006	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019386-007	BREVIBLOC	20MG/ML	INJECTABLE / INJECTION			2003-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019386-003	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION			1988-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019386-004	BREVIBLOC IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019386-005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019386-006	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019386-007	BREVIBLOC	20MG/ML	INJECTABLE / INJECTION			2003-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019386-003	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION			1988-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019386-004	BREVIBLOC IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019386-005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019386-006	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019386-007	BREVIBLOC	20MG/ML	INJECTABLE / INJECTION			2003-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019386-003	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION			1988-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019386-004	BREVIBLOC IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019386-005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019386-006	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019386-007	BREVIBLOC	20MG/ML	INJECTABLE / INJECTION			2003-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019386-003	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION			1988-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019386-004	BREVIBLOC IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019386-005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019386-006	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019386-007	BREVIBLOC	20MG/ML	INJECTABLE / INJECTION			2003-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019386-003	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION			1988-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019386-004	BREVIBLOC IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019386-005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019386-006	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019386-007	BREVIBLOC	20MG/ML	INJECTABLE / INJECTION			2003-05-28	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 93 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N019386-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019386-005	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019386-006	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019386-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019386-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019386-006	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019386-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019386-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019386-006	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019386-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019386-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019386-006	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019386-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019386-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019386-006	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019386-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019386-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019386-006	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019386-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019386-005	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019386-006	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019386-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019386-005	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019386-006	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019386-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019386-005	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019386-006	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019386-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019386-005	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019386-006	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019386-004	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019386-005	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019386-006	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019386-004	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019386-005	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019386-006	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019386-004	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019386-005	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019386-006	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019386-004	AP	1	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019386-004	6310094	2021-01-12		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-004	6528540	2021-01-12		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-004	6310094*PED	2021-07-12	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-004	6528540*PED	2021-07-12	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-005	6310094	2021-01-12		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-005	6528540	2021-01-12		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-005	6310094*PED	2021-07-12	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-005	6528540*PED	2021-07-12	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-006	6310094	2021-01-12		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-006	6528540	2021-01-12		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-006	6310094*PED	2021-07-12	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-006	6528540*PED	2021-07-12	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-007	6310094	2021-01-12		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-007	6528540	2021-01-12		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-007	6310094*PED	2021-07-12	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-007	6528540*PED	2021-07-12	Pediatric extension	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N019386-004	6310094	2021-01-12		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-004	6528540	2021-01-12		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-004	6310094*PED	2021-07-12	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-004	6528540*PED	2021-07-12	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-005	6310094	2021-01-12		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-005	6528540	2021-01-12		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-005	6310094*PED	2021-07-12	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-005	6528540*PED	2021-07-12	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-006	6310094	2021-01-12		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-006	6528540	2021-01-12		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-006	6310094*PED	2021-07-12	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-006	6528540*PED	2021-07-12	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-007	6310094	2021-01-12		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-007	6528540	2021-01-12		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-007	6310094*PED	2021-07-12	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-007	6528540*PED	2021-07-12	Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019386-004	6310094	2021-01-12		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019386-004	6528540	2021-01-12		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019386-004	6310094*PED	2021-07-12	Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019386-004	6528540*PED	2021-07-12	Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019386-005	6310094	2021-01-12		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019386-005	6528540	2021-01-12		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019386-005	6310094*PED	2021-07-12	Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019386-005	6528540*PED	2021-07-12	Pediatric extension	`87673890dc5c…`

Reported adverse events (FAERS/openFDA)#

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