Hydromorphone Hydrochloride

Product NDC: 17856-0386
Requested package NDC: 17856-0386-1
11-digit product format: 178560386
Labeler code: 17856
Product ID: 17856-0386_88cc7d59-5e6c-4f9c-af6b-a4426ba248ad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydromorphone hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA074653
Marketing category: ANDA
Marketing start: 2012-03-01
Marketing end: 0000-00-00
Substance: HYDROMORPHONE HYDROCHLORIDE
Active strength: 1 mg/mL
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2023-12-31
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	17856-0386	17856-0386-1	I	Inactivated by FDA		2026-08-11

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 · 8 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	`9bebd1f3094a…`	`5416666fcb17…`

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

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
A074653-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		1998-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074653-001	AA

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 · 41 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	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074653-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	1998-07-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A074653-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074653-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074653-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074653-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074653-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074653-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074653-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074653-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074653-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074653-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074653-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074653-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074653-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074653-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074653-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074653-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074653-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074653-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074653-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074653-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074653-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074653-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074653-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074653-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074653-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074653-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074653-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074653-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074653-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074653-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074653-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074653-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074653-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074653-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074653-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074653-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074653-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074653-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074653-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074653-001	AA	1	`cb3db0bc1861…`

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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-05-15	These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION. HYDROMORPHONE HYDROCHLORIDE tablets and HYDROMORPHONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1984
2024-01-30	These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION. HYDROMORPHONE HYDROCHLORIDE tablets and HYDROMORPHONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1984
2022-09-22	These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION. HYDROMORPHONE HYDROCHLORIDE tablets and HYDROMORPHONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1984
2020-01-31	These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION. HYDROMORPHONE HYDROCHLORIDE tablets and HYDROMORPHONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-0386-1	Hydromorphone Hydrochloride	72 in 1 CASE	SOLUTION	72		4
17856-0386-2	Hydromorphone Hydrochloride	5 mL in 1 CUP	SOLUTION	5		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17856-0386-1	ML - Milliliter	17856-0386	a3ac3443-c4ca-4c6c-88fb-94d670d967c7	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0386	HYDROMORPHONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.]	4	Legacy NDC, 2 package rows	20240517_2f1449bd-2b80-4383-9336-df9940e87a50.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.	cc574063-6ede-4da7-82c4-7450c92b229b	2026-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074653 application number: ANDA074653

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	2f1449bd-2b80-4383-9336-df9940e87a50	4
897657	hydromorphone hydrochloride 1 MG/ML Oral Solution	SCD	2f1449bd-2b80-4383-9336-df9940e87a50	4
897657	hydromorphone HCl 1 MG per 1 ML Oral Solution	SY	2f1449bd-2b80-4383-9336-df9940e87a50	4
897657	hydromorphone HCl 5 MG per 5 ML Oral Solution	SY	2f1449bd-2b80-4383-9336-df9940e87a50	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-0386-1	17856038601	72 CUP in 1 CASE (17856-0386-1) > 5 mL in 1 CUP (17856-0386-2)	72 cup	2022-09-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydromorphone Hydrochloride	ATLANTIC BIOLOGICALS CORP.	2024-05-15	HUMAN PRESCRIPTION DRUG LABEL	4