Hydromorphone Hydrochloride

Product NDC: 0409-1312
11-digit product format: 004091312
Labeler code: 0409
Product ID: 0409-1312_766e302a-2d03-4d93-b237-2348b57ee517
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROMORPHONE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Hospira, Inc.
Application: NDA200403
Marketing category: NDA
Marketing start: 2021-02-01
Substance: HYDROMORPHONE HYDROCHLORIDE
Active strength: 2 mg/mL
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
N200403-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2011-12-01
N200403-002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2011-12-01
N200403-003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP	2011-12-01
N200403-004	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION		2022-06-13
N200403-005	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION		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 · 174 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
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…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION		2022-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION		2023-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION		2022-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION		2023-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION		2022-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION		2023-03-03	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200403-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200403-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200403-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200403-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200403-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200403-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N200403-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200403-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200403-002	AP	1	`5c6f7cd8ea54…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydromorphone Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROMORPHONE HYDROCHLORIDE	2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L960UP2KRW	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
897756	Internal RxNorm lookup
897757	Internal RxNorm lookup
1433251	Internal RxNorm lookup
1724383	Internal RxNorm lookup
1724644	Internal RxNorm lookup
2675350	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c92985da-a658-b186-e763-2287eda87a86	Product name	3	20250221
96c475b3-58c7-b955-d715-0111804a3e50	Product name	5	20210512
1dd54659-b775-4fa8-a858-7f0e521fbadc	Product name	4	20200925
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0409-1312-03	Hydromorphone Hydrochloride	1 mL in 1 CARTRIDGE	INJECTION, SOLUTION	1	33
0409-1312-30	Hydromorphone Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10	33
0409-1312-16	Hydromorphone Hydrochloride	1 mL in 1 SYRINGE	INJECTION, SOLUTION	1	12
0409-1312-36	Hydromorphone Hydrochloride	10 in 1 CELLO PACK	INJECTION, SOLUTION	10	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-1312-03	ML - Milliliter	0409-1312	2aba610f-f975-441e-828b-dcc5506a3d3a	1	2017-04-05
0409-1312-09	ML - Milliliter	0409-1312	7759126f-d23b-42fe-85e2-4236c0ad06b2	1	2017-07-07
0409-1312-10	ML - Milliliter	0409-1312	8d33a65e-fedc-472e-aa28-7fe41667be08	1	2012-07-24
0409-1312-16	ML - Milliliter	0409-1312	499deb74-6da5-410b-a9dd-300723eb2a2a	1	2021-03-02
0409-1312-30	ML - Milliliter	0409-1312	5d73a474-3839-4d44-b337-3c5570def18a	1	2012-07-24
0409-1312-36	ML - Milliliter	0409-1312	1e8b724f-6f88-4354-8a85-d16b4197bb46	1	2021-03-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROMORPHONE HYDROCHLORIDE	ACTIVE INGREDIENT	L960UP2KRW	HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
HYDROMORPHONE	ACTIVE MOIETY	Q812464R06	HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
LACTIC ACID, UNSPECIFIED FORM	INACTIVE INGREDIENT	33X04XA5AT	HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
SODIUM LACTATE	INACTIVE INGREDIENT	TU7HW0W0QT	HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-1312	HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	30	Current NDC, Legacy NDC, 2 package rows	20241206_e9c9ef18-7dfc-4322-b2fc-29b934c30f8b.zip
0409-1312	HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	9	Current NDC, Legacy NDC, 2 package rows	20240517_f9ca2ef5-46d8-475a-a26e-f7c8becd6db7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 200403 application number: NDA200403 ndc (product): 0409-1312
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 200403 application number: NDA200403 ndc (product): 0409-1312

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L960UP2KRW	HYDROMORPHONE HYDROCHLORIDE	71-68-1	HYDROMORPHONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1724383	HYDROmorphone HCl 1 MG in 1 ML Cartridge	PSN	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
897653	HYDROmorphone HCl 1 MG in 1 ML Injection	PSN	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
897756	HYDROmorphone HCl 1 MG in 1 ML Prefilled Syringe	PSN	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
1724644	HYDROmorphone HCl 2 MG in 1 ML Cartridge	PSN	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
1724276	HYDROmorphone HCl 2 MG in 1 ML Injection	PSN	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
897757	HYDROmorphone HCl 2 MG in 1 ML Prefilled Syringe	PSN	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
897758	HYDROmorphone HCl 4 MG in 1 ML Cartridge	PSN	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
897753	HYDROmorphone HCl 4 MG in 1 ML Injection	PSN	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
1724383	1 ML hydromorphone hydrochloride 1 MG/ML Cartridge	SCD	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
897653	1 ML hydromorphone hydrochloride 1 MG/ML Injection	SCD	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
897756	1 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe	SCD	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
1724644	1 ML hydromorphone hydrochloride 2 MG/ML Cartridge	SCD	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
1724276	1 ML hydromorphone hydrochloride 2 MG/ML Injection	SCD	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
897757	1 ML hydromorphone hydrochloride 2 MG/ML Prefilled Syringe	SCD	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
897758	1 ML hydromorphone hydrochloride 4 MG/ML Cartridge	SCD	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
897753	1 ML hydromorphone hydrochloride 4 MG/ML Injection	SCD	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
1724383	hydromorphone HCl 1 MG per 1 ML Cartridge	SY	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
897653	hydromorphone HCl 1 MG per 1 ML Injection	SY	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
897756	hydromorphone HCl 1 MG per 1 ML Prefilled Syringe	SY	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
1724644	hydromorphone HCl 2 MG per 1 ML Cartridge	SY	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
1724276	hydromorphone HCl 2 MG per 1 ML Injection	SY	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
897757	hydromorphone HCl 2 MG per 1 ML Prefilled Syringe	SY	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
897758	hydromorphone HCl 4 MG per 1 ML Cartridge	SY	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
897753	hydromorphone HCl 4 MG per 1 ML Injection	SY	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	33
1433251	HYDROmorphone HCl 0.5 MG in 0.5 ML Prefilled Syringe	PSN	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	12
1724383	HYDROmorphone HCl 1 MG in 1 ML Cartridge	PSN	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	12
897756	HYDROmorphone HCl 1 MG in 1 ML Prefilled Syringe	PSN	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	12
1724644	HYDROmorphone HCl 2 MG in 1 ML Cartridge	PSN	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	12
897757	HYDROmorphone HCl 2 MG in 1 ML Prefilled Syringe	PSN	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	12
2675350	HYDROmorphone hydrochloride 0.25 MG in 0.5 ML Prefilled Syringe	PSN	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	12
2675350	0.5 ML hydromorphone hydrochloride 0.5 MG/ML Prefilled Syringe	SCD	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	12
1433251	0.5 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe	SCD	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	12
1724383	1 ML hydromorphone hydrochloride 1 MG/ML Cartridge	SCD	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	12
897756	1 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe	SCD	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	12
1724644	1 ML hydromorphone hydrochloride 2 MG/ML Cartridge	SCD	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	12
897757	1 ML hydromorphone hydrochloride 2 MG/ML Prefilled Syringe	SCD	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	12
1433251	hydromorphone HCl 0.5 MG per 0.5 ML Prefilled Syringe	SY	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	12
1724383	hydromorphone HCl 1 MG per 1 ML Cartridge	SY	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	12
897756	hydromorphone HCl 1 MG per 1 ML Prefilled Syringe	SY	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	12
1724644	hydromorphone HCl 2 MG per 1 ML Cartridge	SY	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	12
897757	hydromorphone HCl 2 MG per 1 ML Prefilled Syringe	SY	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	12
2675350	hydromorphone hydrochloride 0.25 MG per 0.5 ML Prefilled Syringe	SY	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-1312-03	00409131203	1 mL in 1 CARTRIDGE	1 ml					Historical
0409-1312-16	00409131216	1 mL in 1 SYRINGE	1 ml					Historical
0409-1312-30	00409131230	10 CARTRIDGE in 1 CARTON (0409-1312-30) / 1 mL in 1 CARTRIDGE (0409-1312-03)	10 cartridge	2011-12-01	0000-00-00	No	No	Current
0409-1312-36	00409131236	10 SYRINGE in 1 CELLO PACK (0409-1312-36) / 1 mL in 1 SYRINGE (0409-1312-16)	10 syringe	2021-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydromorphone Hydrochloride	Hospira, Inc.	2026-02-04	HUMAN PRESCRIPTION DRUG LABEL	12
Hydromorphone Hydrochloride	Hospira, Inc.	2025-12-31	HUMAN PRESCRIPTION DRUG LABEL	33