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 02:13:37

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
0409-1312-10	ML - Milliliter	0409-1312	8d33a65e-fedc-472e-aa28-7fe41667be08	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0409-1312	0409-1312-10

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 44.

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
N200403-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-12-01
N200403-002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-12-01
N200403-003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-12-01
N200403-004	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION		RLD	2022-06-13
N200403-005	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION		RLD	2023-03-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N200403-001	AP
N200403-002	AP
N200403-003	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 5 · 189 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
2026-10-15 13:18:30	2026-09	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-12-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-12-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-12-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION		RLD	2022-06-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION		RLD	2023-03-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION		RLD	2022-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION		RLD	2023-03-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP		2011-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP		2011-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP		2011-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION			2022-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION			2023-03-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP		2011-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP		2011-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP		2011-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION			2022-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION			2023-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP		2011-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP		2011-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP		2011-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION			2022-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION			2023-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP		2011-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP		2011-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP		2011-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION			2022-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION			2023-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP		2011-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP		2011-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP		2011-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION			2022-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION			2023-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP		2011-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP		2011-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP		2011-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION			2022-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION			2023-03-03	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N200403-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N200403-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N200403-003	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N200403-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200403-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200403-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N200403-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200403-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200403-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200403-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200403-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200403-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200403-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200403-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200403-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200403-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200403-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200403-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200403-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200403-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200403-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200403-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200403-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200403-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200403-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200403-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200403-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200403-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200403-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200403-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200403-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200403-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200403-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200403-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200403-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200403-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200403-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200403-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200403-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200403-001	AP	1	`79d66fd596c7…`

Reported adverse events (FAERS/openFDA)#

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