Hydromorphone Hydrochloride

Product NDC: 0641-6254
11-digit product format: 006416254
Labeler code: 0641
Product ID: 0641-6254_68e84ae8-2bd5-4f57-abef-4d0cde3c4775
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydromorphone Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: NDA217812
Marketing category: NDA
Marketing start: 2025-05-13
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217812-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2023-12-14

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217812-001	12653820	2043-01-10	U-4571	Drug product	2026-07-14

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.

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	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217812-001	HYDROMORPHONE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2023-12-14	`a50c72e98297…`

Observed Orange Book patent history#

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	N217812-001	12653820	2043-01-10	U-4571	Drug product	2026-07-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217812-001	12653820	2043-01-10	U-4571	Drug product	2026-07-14	`caaa826d4ba7…`

Reported adverse events (FAERS/openFDA)#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
897745	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
c729424e-e483-4bf8-b86c-ce56636dcffa	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6254-01	Hydromorphone Hydrochloride	1 in 1 CARTON	INJECTION, SOLUTION	1		1
0641-6254-01	Hydromorphone Hydrochloride	20 mL in 1 VIAL	INJECTION, SOLUTION	20		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6254-01	ML - Milliliter	0641-6254	79f5f971-4d40-41a5-b267-fae3d2254c20	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6254	HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	1	Current NDC, 2 package rows	20250519_c729424e-e483-4bf8-b86c-ce56636dcffa.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	c729424e-e483-4bf8-b86c-ce56636dcffa	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 217812 application number: NDA217812 ndc (product): 0641-6254

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
897745	HYDROmorphone HCl 2 MG/ML Injectable Solution	PSN	c729424e-e483-4bf8-b86c-ce56636dcffa	1
897745	hydromorphone hydrochloride 2 MG/ML Injectable Solution	SCD	c729424e-e483-4bf8-b86c-ce56636dcffa	1
897745	hydromorphone HCl 2 MG/ML Injectable Solution	SY	c729424e-e483-4bf8-b86c-ce56636dcffa	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0641-6254-01	00641625401	1 VIAL in 1 CARTON (0641-6254-01) / 20 mL in 1 VIAL	1 vial	2025-05-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydromorphone Hydrochloride	Hikma Pharmaceuticals USA Inc.	2025-12-31	HUMAN PRESCRIPTION DRUG LABEL	2