hydromorphone hydrochloride

Product NDC: 43602-268
Requested package NDC: 43602-268-30
11-digit product format: 436020268
Labeler code: 43602
Product ID: 43602-268_728caa01-5e35-4d0e-b15a-d716cd48c34f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydromorphone hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Ascent Pharmaceuticals, Inc.
Application: ANDA212133
Marketing category: ANDA
Marketing start: 2020-09-24
Marketing end: 0000-00-00
Substance: HYDROMORPHONE HYDROCHLORIDE
Active strength: 16 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	43602-268	43602-268-30	D	Discontinued by firm		2026-08-17

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43602-268	43602-268-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A212133-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23
A212133-002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23
A212133-003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23
A212133-004	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212133-001	AB
A212133-002	AB
A212133-003	AB
A212133-004	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 4 · 152 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
2026-08-18 06:07:40	2026-07	A212133-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212133-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212133-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212133-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212133-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212133-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212133-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212133-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212133-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212133-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212133-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212133-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212133-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212133-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212133-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212133-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212133-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212133-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212133-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212133-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212133-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212133-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212133-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212133-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212133-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212133-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212133-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212133-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212133-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212133-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212133-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212133-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212133-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212133-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212133-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212133-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212133-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212133-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212133-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212133-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-23	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212133-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212133-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212133-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212133-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212133-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212133-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212133-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212133-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212133-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212133-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212133-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212133-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212133-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212133-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212133-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212133-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212133-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212133-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212133-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212133-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212133-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212133-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212133-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212133-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212133-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212133-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212133-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212133-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212133-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212133-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212133-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212133-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212133-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212133-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212133-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212133-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212133-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212133-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212133-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212133-004	AB	1	`d8e5a09893c0…`

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43602-268	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCENT PHARMACEUTICALS, INC.]	3	Legacy NDC	20201016_59b1e29f-3292-422c-bfdc-56803436c0ba.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	Camber Pharmaceuticals, Inc.	c33e6320-4206-4b69-8cac-ebfc2351b8f2	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212133 application number: ANDA212133
hydromorphone hydrochloride	HYDROMORPHONE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	90bda45c-9dbe-4ed5-91d0-df8446ad7026	2024-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212133 application number: ANDA212133

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43602-268-30	43602026830	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-268-30)	2020-09-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
hydromorphone hydrochloride	Ascent Pharmaceuticals, Inc.	2020-09-24	HUMAN PRESCRIPTION DRUG LABEL	3