Hydromorphone Hydrochloride

Product NDC: 42858-303
11-digit product format: 428580303
Labeler code: 42858
Product ID: 42858-303_b786b01b-46f9-4a00-a667-699e813a741b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydromorphone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Rhodes Pharmaceuticals LLC
Application: NDA019892
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2009-11-23
Substance: HYDROMORPHONE HYDROCHLORIDE
Active strength: 8 mg/1
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019892-001	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07
N019892-002	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	RLD	2007-11-09
N019892-003	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	RLD	2007-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019892-001	AB
N019892-002	AB
N019892-003	AB

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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019892-002	DILAUDID	4MG	TABLET / ORAL	AB	RLD	2007-11-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019892-003	DILAUDID	2MG	TABLET / ORAL	AB	RLD	2007-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019892-001	DILAUDID	8MG	TABLET / ORAL	AB	RLD, RS	1992-12-07	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N019892-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019892-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019892-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019892-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019892-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019892-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019892-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019892-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019892-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019892-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019892-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019892-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019892-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019892-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019892-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019892-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019892-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019892-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019892-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019892-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019892-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019892-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019892-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019892-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019892-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019892-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019892-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019892-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019892-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019892-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019892-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019892-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019892-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019892-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019892-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019892-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019892-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019892-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019892-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019892-001	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019892-001	6589960	2020-11-09	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019892-002	6589960	2020-11-09	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019892-003	6589960	2020-11-09	Drug substance, Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N019892-001	6589960	2020-11-09	Drug substance, Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019892-002	6589960	2020-11-09	Drug substance, Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019892-003	6589960	2020-11-09	Drug substance, Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019892-001	6589960	2020-11-09	Drug substance, Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019892-002	6589960	2020-11-09	Drug substance, Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019892-003	6589960	2020-11-09	Drug substance, Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019892-001	6589960	2020-11-09	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019892-002	6589960	2020-11-09	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019892-003	6589960	2020-11-09	Drug substance, Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019892-001	6589960	2020-11-09	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019892-002	6589960	2020-11-09	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019892-003	6589960	2020-11-09	Drug substance, Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019892-001	6589960	2020-11-09	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019892-002	6589960	2020-11-09	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019892-003	6589960	2020-11-09	Drug substance, Drug product	`ea99ee380514…`

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	8 mg/1

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
897657	Internal RxNorm lookup
897696	Internal RxNorm lookup
897702	Internal RxNorm lookup
897710	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
37565441-0d95-4743-a695-d7b3326f58a1	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
42858-303-01	Hydromorphone Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET	100		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42858-303-01	EA - Each	42858-303	6732a978-5a0c-4eee-aa74-7dc3954ab6f8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROMORPHONE HYDROCHLORIDE	ACTIVE INGREDIENT	L960UP2KRW	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]	10
HYDROMORPHONE	ACTIVE MOIETY	Q812464R06	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]	10
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]	10
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]	10
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]	10
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]	10
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]	10
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]	10
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]	10
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]	10
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]	10
HYDROMORPHONE HYDROCHLORIDE	ACTIVE INGREDIENT	L960UP2KRW	HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
HYDROMORPHONE	ACTIVE MOIETY	Q812464R06	HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42858-303	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]	16	Current NDC, Legacy NDC, 1 package rows	20240119_37565441-0d95-4743-a695-d7b3326f58a1.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Bryant Ranch Prepack	2427814c-f32b-8ac5-99b8-5e886fd2d001	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019892 application number: NDA019892
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	53ddcacc-99e4-8b21-e063-6394a90a3e79	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019892 application number: NDA019892
Dilaudid	HYDROMORPHONE HYDROCHLORIDE	Rhodes Pharmaceuticals LLC	d6b40e39-a57e-402c-b4f6-7041e832f837	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019892 application number: NDA019892
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Rhodes Pharmaceuticals LLC	37565441-0d95-4743-a695-d7b3326f58a1	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019892 application number: NDA019892 ndc (product): 42858-303
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Bryant Ranch Prepack	c48e2e9a-cb5b-46b8-b6be-3dd76e80d0ca	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019892 application number: NDA019892
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	ASCLEMED USA INC.	18f6f54e-1537-4181-9d07-54ddf881a9ee	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019892 application number: NDA019892

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
897657	HYDROmorphone HCl 1 MG in 1 mL Oral Solution	PSN	37565441-0d95-4743-a695-d7b3326f58a1	20
897696	HYDROmorphone HCl 2 MG Oral Tablet	PSN	37565441-0d95-4743-a695-d7b3326f58a1	20
897702	HYDROmorphone HCl 4 MG Oral Tablet	PSN	37565441-0d95-4743-a695-d7b3326f58a1	20
897710	HYDROmorphone HCl 8 MG Oral Tablet	PSN	37565441-0d95-4743-a695-d7b3326f58a1	20
897657	hydromorphone hydrochloride 1 MG/ML Oral Solution	SCD	37565441-0d95-4743-a695-d7b3326f58a1	20
897696	hydromorphone hydrochloride 2 MG Oral Tablet	SCD	37565441-0d95-4743-a695-d7b3326f58a1	20
897702	hydromorphone hydrochloride 4 MG Oral Tablet	SCD	37565441-0d95-4743-a695-d7b3326f58a1	20
897710	hydromorphone hydrochloride 8 MG Oral Tablet	SCD	37565441-0d95-4743-a695-d7b3326f58a1	20
897657	hydromorphone HCl 1 MG per 1 ML Oral Solution	SY	37565441-0d95-4743-a695-d7b3326f58a1	20
897657	hydromorphone HCl 5 MG per 5 ML Oral Solution	SY	37565441-0d95-4743-a695-d7b3326f58a1	20
897696	HYDROmorphone HCl 2 MG Oral Tablet	PSN	18f6f54e-1537-4181-9d07-54ddf881a9ee	1
897702	HYDROmorphone HCl 4 MG Oral Tablet	PSN	18f6f54e-1537-4181-9d07-54ddf881a9ee	1
897710	HYDROmorphone HCl 8 MG Oral Tablet	PSN	86638efd-9eb9-440e-b48b-b1bd52ccbc61	1
897710	HYDROmorphone HCl 8 MG Oral Tablet	PSN	18f6f54e-1537-4181-9d07-54ddf881a9ee	1
897696	hydromorphone hydrochloride 2 MG Oral Tablet	SCD	18f6f54e-1537-4181-9d07-54ddf881a9ee	1
897702	hydromorphone hydrochloride 4 MG Oral Tablet	SCD	18f6f54e-1537-4181-9d07-54ddf881a9ee	1
897710	hydromorphone hydrochloride 8 MG Oral Tablet	SCD	18f6f54e-1537-4181-9d07-54ddf881a9ee	1
897710	hydromorphone hydrochloride 8 MG Oral Tablet	SCD	86638efd-9eb9-440e-b48b-b1bd52ccbc61	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42858-303-01	42858030301	100 TABLET in 1 BOTTLE, PLASTIC (42858-303-01)	100 tablet	2009-11-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydromorphone Hydrochloride	Rhodes Pharmaceuticals LLC \| Knoa Pharmaceuticals LLC	2026-05-14	HUMAN PRESCRIPTION DRUG LABEL	20
Hydromorphone Hydrochloride	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-12-04	HUMAN PRESCRIPTION DRUG LABEL	1
HYDROMORPHONE HYDROCHLORIDE - STAT RX USA LLC	STAT RX USA LLC	2011-08-23	HUMAN PRESCRIPTION DRUG LABEL	1