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 02:29:56

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
59011-442-10	ML - Milliliter	59011-442	b2b8558e-c702-48c2-9133-a7bf727103e4	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59011-442	59011-442-10

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	TE codes	RLD / RS	Approval date
N019034-001	DILAUDID-HP	HYDROMORPHONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-01-11
N019034-002	DILAUDID-HP	HYDROMORPHONE HYDROCHLORIDE	250MG/VIAL	INJECTABLE / INJECTION			1994-08-04
N019034-003	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30
N019034-004	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30
N019034-005	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30
N019034-006	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2020-01-16
N019034-007	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019034-001	AP
N019034-003	AP
N019034-004	AP
N019034-005	AP
N019034-006	AP
N019034-007	AP

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N019034-001	9731082	2032-04-23	Drug product	2018-02-05
N019034-001	9248229	2034-03-12	Drug product	2018-02-05
N019034-002	9731082	2032-04-23	Drug product	2018-02-05
N019034-002	9248229	2034-03-12	Drug product	2018-02-05
N019034-003	9731082	2032-04-23	Drug product	2018-02-05
N019034-003	9248229	2034-03-12	Drug product	2018-02-05
N019034-004	9731082	2032-04-23	Drug product	2018-02-05
N019034-004	9248229	2034-03-12	Drug product	2018-02-05
N019034-005	9731082	2032-04-23	Drug product	2018-02-05
N019034-005	9248229	2034-03-12	Drug product	2018-02-05
N019034-006	9731082	2032-04-23	Drug product	2023-05-23
N019034-006	9248229	2034-03-12	Drug product	2023-05-23
N019034-007	9731082	2032-04-23	Drug product	2018-02-05
N019034-007	9248229	2034-03-12	Drug product	2018-02-05

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 · 273 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	N019034-001	DILAUDID-HP	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-002	DILAUDID-HP	250MG/VIAL	INJECTABLE / INJECTION			1994-08-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-003	DILAUDID	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-004	DILAUDID	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-005	DILAUDID	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-006	DILAUDID	0.2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2020-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-007	DILAUDID	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-02-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019034-001	DILAUDID-HP	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-002	DILAUDID-HP	250MG/VIAL	INJECTABLE / INJECTION			1994-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-003	DILAUDID	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-004	DILAUDID	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-005	DILAUDID	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-006	DILAUDID	0.2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2020-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-007	DILAUDID	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-02-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019034-001	DILAUDID-HP	10MG/ML	INJECTABLE / INJECTION		RLD	1984-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-002	DILAUDID-HP	250MG/VIAL	INJECTABLE / INJECTION			1994-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-003	DILAUDID	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-004	DILAUDID	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-005	DILAUDID	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-006	DILAUDID	0.2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2020-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-007	DILAUDID	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-001	DILAUDID-HP	10MG/ML	INJECTABLE / INJECTION		RLD	1984-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-002	DILAUDID-HP	250MG/VIAL	INJECTABLE / INJECTION			1994-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-003	DILAUDID	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-004	DILAUDID	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-005	DILAUDID	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-006	DILAUDID	0.2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2020-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-007	DILAUDID	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019034-001	DILAUDID-HP	10MG/ML	INJECTABLE / INJECTION		RLD	1984-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-002	DILAUDID-HP	250MG/VIAL	INJECTABLE / INJECTION			1994-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-003	DILAUDID	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-004	DILAUDID	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-005	DILAUDID	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-006	DILAUDID	0.2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2020-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-007	DILAUDID	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-001	DILAUDID-HP	10MG/ML	INJECTABLE / INJECTION		RLD	1984-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-002	DILAUDID-HP	250MG/VIAL	INJECTABLE / INJECTION			1994-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-003	DILAUDID	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-004	DILAUDID	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-005	DILAUDID	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 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	N019034-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-005	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-006	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-007	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019034-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-006	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-007	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019034-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-006	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-007	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-006	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-007	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019034-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-006	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-007	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-006	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-007	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019034-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019034-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019034-005	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019034-006	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019034-007	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019034-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019034-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019034-005	AP	1	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 546 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019034-001	9731082	2032-04-23	Drug product	2018-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-001	9248229	2034-03-12	Drug product	2018-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-002	9731082	2032-04-23	Drug product	2018-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-002	9248229	2034-03-12	Drug product	2018-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-003	9731082	2032-04-23	Drug product	2018-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-003	9248229	2034-03-12	Drug product	2018-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-004	9731082	2032-04-23	Drug product	2018-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-004	9248229	2034-03-12	Drug product	2018-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-005	9731082	2032-04-23	Drug product	2018-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-005	9248229	2034-03-12	Drug product	2018-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-006	9731082	2032-04-23	Drug product	2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-006	9248229	2034-03-12	Drug product	2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-007	9731082	2032-04-23	Drug product	2018-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019034-007	9248229	2034-03-12	Drug product	2018-02-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019034-001	9731082	2032-04-23	Drug product	2018-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-001	9248229	2034-03-12	Drug product	2018-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-002	9731082	2032-04-23	Drug product	2018-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-002	9248229	2034-03-12	Drug product	2018-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-003	9731082	2032-04-23	Drug product	2018-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-003	9248229	2034-03-12	Drug product	2018-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-004	9731082	2032-04-23	Drug product	2018-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-004	9248229	2034-03-12	Drug product	2018-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-005	9731082	2032-04-23	Drug product	2018-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-005	9248229	2034-03-12	Drug product	2018-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-006	9731082	2032-04-23	Drug product	2023-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-006	9248229	2034-03-12	Drug product	2023-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-007	9731082	2032-04-23	Drug product	2018-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019034-007	9248229	2034-03-12	Drug product	2018-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019034-001	9731082	2032-04-23	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-001	9248229	2034-03-12	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-002	9731082	2032-04-23	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-002	9248229	2034-03-12	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-003	9731082	2032-04-23	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-003	9248229	2034-03-12	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-004	9731082	2032-04-23	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-004	9248229	2034-03-12	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-005	9731082	2032-04-23	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-005	9248229	2034-03-12	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-006	9731082	2032-04-23	Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-006	9248229	2034-03-12	Drug product	2023-05-23	`011fe1cb6892…`

Reported adverse events (FAERS/openFDA)#

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