Hydromorphone Hydrochloride

Product NDC: 0641-6206
11-digit product format: 006416206
Labeler code: 0641
Product ID: 0641-6206_08fdd324-f2ce-4a29-a6d1-fc88aa10b7ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydromorphone Hydrochloride
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA216899
Marketing category: ANDA
Marketing start: 2024-04-26
Substance: HYDROMORPHONE HYDROCHLORIDE
Active strength: .5 mg/.5mL
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A216899-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09
A216899-002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	2024-02-09
A216899-003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2024-02-09
A216899-004	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A216899-001	AP
A216899-002	AP
A216899-003	AP
A216899-004	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 2 · 64 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	A216899-001	HYDROMORPHONE HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216899-002	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	2024-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216899-003	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216899-004	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216899-001	HYDROMORPHONE HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216899-002	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	2024-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216899-003	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216899-004	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216899-001	HYDROMORPHONE HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216899-002	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	2024-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216899-003	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216899-004	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216899-001	HYDROMORPHONE HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216899-002	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	2024-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216899-003	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216899-004	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216899-001	HYDROMORPHONE HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216899-002	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	2024-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216899-003	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216899-004	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216899-001	HYDROMORPHONE HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216899-002	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	2024-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216899-003	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216899-004	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216899-001	HYDROMORPHONE HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216899-002	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	2024-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216899-003	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216899-004	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216899-001	HYDROMORPHONE HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216899-002	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	2024-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216899-003	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216899-004	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216899-001	HYDROMORPHONE HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216899-002	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	2024-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216899-003	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216899-004	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216899-001	HYDROMORPHONE HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216899-002	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	2024-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216899-003	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216899-004	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2024-02-09	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 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	A216899-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216899-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216899-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216899-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216899-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216899-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216899-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216899-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216899-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216899-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216899-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216899-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216899-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216899-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216899-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216899-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216899-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216899-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216899-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216899-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216899-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216899-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216899-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216899-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216899-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216899-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216899-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216899-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216899-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216899-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216899-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216899-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216899-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216899-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216899-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216899-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216899-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216899-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216899-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216899-004	AP	1	`d06236e962d9…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216899-001	PC	2025-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216899-001	PC	2025-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216899-001	PC	2025-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216899-001	PC	2025-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216899-001	PC	2025-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216899-002	PC	2024-11-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216899-003	PC	2024-12-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216899-001	PC	2025-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216899-002	PC	2024-11-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216899-003	PC	2024-12-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216899-002	PC	2024-11-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216899-003	PC	2024-12-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216899-001	PC	2025-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216899-002	PC	2024-11-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216899-003	PC	2024-12-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216899-002	PC	2024-11-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216899-003	PC	2024-12-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216899-002	PC	2024-11-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216899-003	PC	2024-12-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216899-002	PC	2024-11-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216899-003	PC	2024-12-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216899-002	PC	2024-11-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216899-003	PC	2024-12-02	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydromorphone Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROMORPHONE HYDROCHLORIDE	.5 mg/.5mL

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
897756	Internal RxNorm lookup
897757	Internal RxNorm lookup
1433251	Internal RxNorm lookup
2277368	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
31d5a37a-0e90-4e88-be14-75c877be9de2	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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6206-01	Hydromorphone Hydrochloride	0.5 mL in 1 SYRINGE	INJECTION	0.5		3
0641-6206-10	Hydromorphone Hydrochloride	10 in 1 CARTON	INJECTION	10		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6206-01	ML - Milliliter	0641-6206	2397a268-7e91-45c5-b50d-31aba8ef3a4b	1	2024-05-16
0641-6206-10	ML - Milliliter	0641-6206	d412778b-4db4-443a-a08c-b7df66937faf	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6206	HYDROMORPHONE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]	3	Current NDC, 2 package rows	20240509_31d5a37a-0e90-4e88-be14-75c877be9de2.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.	31d5a37a-0e90-4e88-be14-75c877be9de2	2024-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216899 application number: ANDA216899 ndc (product): 0641-6206

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
1433251	HYDROmorphone HCl 0.5 MG in 0.5 ML Prefilled Syringe	PSN	31d5a37a-0e90-4e88-be14-75c877be9de2	3
897756	HYDROmorphone HCl 1 MG in 1 ML Prefilled Syringe	PSN	31d5a37a-0e90-4e88-be14-75c877be9de2	3
897757	HYDROmorphone HCl 2 MG in 1 ML Prefilled Syringe	PSN	31d5a37a-0e90-4e88-be14-75c877be9de2	3
2277368	HYDROmorphone hydrochloride 0.2 MG in 1 mL Prefilled Syringe	PSN	31d5a37a-0e90-4e88-be14-75c877be9de2	3
1433251	0.5 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe	SCD	31d5a37a-0e90-4e88-be14-75c877be9de2	3
2277368	1 ML hydromorphone hydrochloride 0.2 MG/ML Prefilled Syringe	SCD	31d5a37a-0e90-4e88-be14-75c877be9de2	3
897756	1 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe	SCD	31d5a37a-0e90-4e88-be14-75c877be9de2	3
897757	1 ML hydromorphone hydrochloride 2 MG/ML Prefilled Syringe	SCD	31d5a37a-0e90-4e88-be14-75c877be9de2	3
1433251	hydromorphone HCl 0.5 MG per 0.5 ML Prefilled Syringe	SY	31d5a37a-0e90-4e88-be14-75c877be9de2	3
897756	hydromorphone HCl 1 MG per 1 ML Prefilled Syringe	SY	31d5a37a-0e90-4e88-be14-75c877be9de2	3
897757	hydromorphone HCl 2 MG per 1 ML Prefilled Syringe	SY	31d5a37a-0e90-4e88-be14-75c877be9de2	3
2277368	hydromorphone hydrochloride 0.2 MG per 1 ML Prefilled Syringe	SY	31d5a37a-0e90-4e88-be14-75c877be9de2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0641-6206-01	00641620601	0.5 mL in 1 SYRINGE	0.5 ml				Historical
0641-6206-10	00641620610	10 SYRINGE in 1 CARTON (0641-6206-10) / .5 mL in 1 SYRINGE (0641-6206-01)	10 syringe	2024-04-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydromorphone Hydrochloride	Hikma Pharmaceuticals USA Inc.	2024-05-08	HUMAN PRESCRIPTION DRUG LABEL	3