hydromorphone hydrochloride

Product NDC: 0574-0293
11-digit product format: 005740293
Labeler code: 0574
Product ID: 0574-0293_8b576b81-17fc-4251-acc3-6e1b9e18030c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydromorphone hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Padagis US LLC
Application: ANDA204278
Marketing category: ANDA
Marketing start: 2015-05-22
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204278-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06
A204278-002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06
A204278-003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06
A204278-004	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204278-001	AB
A204278-002	AB
A204278-003	AB
A204278-004	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 5 · 164 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	A204278-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204278-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204278-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204278-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204278-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204278-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204278-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204278-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204278-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204278-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204278-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204278-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204278-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204278-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204278-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204278-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204278-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204278-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204278-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204278-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204278-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204278-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204278-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204278-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204278-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204278-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204278-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204278-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204278-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204278-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204278-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204278-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204278-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204278-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204278-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204278-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204278-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204278-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204278-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204278-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-09-20	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A204278-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204278-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204278-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204278-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204278-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204278-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204278-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204278-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204278-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204278-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204278-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204278-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204278-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204278-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204278-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204278-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204278-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204278-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204278-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204278-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204278-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204278-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204278-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204278-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204278-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204278-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204278-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204278-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204278-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204278-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204278-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204278-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204278-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204278-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204278-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204278-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204278-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204278-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204278-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204278-004	AB	1	`d06236e962d9…`

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
902729	Internal RxNorm lookup
902736	Internal RxNorm lookup
902741	Internal RxNorm lookup
1306898	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
780a2616-0392-4715-bc50-71799bea1957	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
0574-0293-01	hydromorphone hydrochloride	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0574-0293-01	EA - Each	0574-0293	630f4701-d5ca-4fbd-899f-4e00d8d9f5eb	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROMORPHONE HYDROCHLORIDE	ACTIVE INGREDIENT	L960UP2KRW	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
HYDROMORPHONE	ACTIVE MOIETY	Q812464R06	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
AMMONIO METHACRYLATE COPOLYMER TYPE A	INACTIVE INGREDIENT	8GQS4E66YY	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
ETHYLCELLULOSE (100 MPA.S)	INACTIVE INGREDIENT	47MLB0F1MV	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0574-0293	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADAGIS US LLC]	17	Current NDC, Legacy NDC, 1 package rows	20240116_780a2616-0392-4715-bc50-71799bea1957.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	Padagis US LLC	780a2616-0392-4715-bc50-71799bea1957	2025-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204278 application number: ANDA204278 ndc (product): 0574-0293

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
902729	HYDROmorphone HCl 12 MG 24HR Extended Release Oral Tablet	PSN	780a2616-0392-4715-bc50-71799bea1957	20
902736	HYDROmorphone HCl 16 MG 24HR Extended Release Oral Tablet	PSN	780a2616-0392-4715-bc50-71799bea1957	20
1306898	HYDROmorphone HCl 32 MG 24HR Extended Release Oral Tablet	PSN	780a2616-0392-4715-bc50-71799bea1957	20
902741	HYDROmorphone HCl 8 MG 24HR Extended Release Oral Tablet	PSN	780a2616-0392-4715-bc50-71799bea1957	20
902729	24 HR hydromorphone hydrochloride 12 MG Extended Release Oral Tablet	SCD	780a2616-0392-4715-bc50-71799bea1957	20
902736	24 HR hydromorphone hydrochloride 16 MG Extended Release Oral Tablet	SCD	780a2616-0392-4715-bc50-71799bea1957	20
1306898	24 HR hydromorphone hydrochloride 32 MG Extended Release Oral Tablet	SCD	780a2616-0392-4715-bc50-71799bea1957	20
902741	24 HR hydromorphone hydrochloride 8 MG Extended Release Oral Tablet	SCD	780a2616-0392-4715-bc50-71799bea1957	20
902729	hydromorphone hydrochloride 12 MG 24 HR Extended Release Oral Tablet	SY	780a2616-0392-4715-bc50-71799bea1957	20
902736	hydromorphone hydrochloride 16 MG 24 HR Extended Release Oral Tablet	SY	780a2616-0392-4715-bc50-71799bea1957	20
1306898	hydromorphone hydrochloride 32 MG 24 HR Extended Release Oral Tablet	SY	780a2616-0392-4715-bc50-71799bea1957	20
902741	hydromorphone hydrochloride 8 MG 24 HR Extended Release Oral Tablet	SY	780a2616-0392-4715-bc50-71799bea1957	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0574-0293-01	00574029301	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0574-0293-01)	2015-05-22	0000-00-00	No	No	Current