Hydromorphone Hydrochloride

Product NDC: 52959-413
11-digit product format: 529590413
Labeler code: 52959
Product ID: 52959-413_0a9c8629-be18-4f5d-8f19-e96b46d63dbd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydromorphone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA077471
Marketing category: ANDA
Marketing start: 2009-12-09
Marketing end: 0000-00-00
Substance: HYDROMORPHONE HYDROCHLORIDE
Active strength: 8 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-413		I	Inactivated by FDA	2026-08-11
excluded package	package	52959-413	52959-413-02	I	Inactivated by FDA	2026-08-11
excluded package	package	52959-413	52959-413-60	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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-413-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-413-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-413-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-413-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-413-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-413-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-413-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-413-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-413-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-413-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-413-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-413-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-413-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-413-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-413-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-413-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-413-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-413-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-413-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-413-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-413-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-413-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-413-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-413-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-413-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-413-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-413-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-413-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-413-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-413-60	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52959-413-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52959-413-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52959-413-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52959-413-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52959-413-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52959-413-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	52959-413-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	52959-413-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52959-413-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52959-413-60	`e2bbac7714bc…`	`27bdfed8d636…`

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	Approval date
A077471-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2009-12-09
A077471-002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2009-12-09
A077471-003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2009-12-09

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077471-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2009-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077471-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2009-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077471-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2009-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077471-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2009-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077471-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2009-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077471-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2009-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077471-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2009-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077471-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2009-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077471-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2009-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077471-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2009-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077471-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2009-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077471-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2009-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077471-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2009-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077471-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2009-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077471-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2009-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077471-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2009-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077471-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2009-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077471-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2009-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077471-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2009-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077471-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2009-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077471-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2009-12-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077471-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2009-12-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077471-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2009-12-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077471-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2009-12-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077471-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2009-12-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077471-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2009-12-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077471-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2009-12-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077471-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2009-12-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077471-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2009-12-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077471-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2009-12-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077471-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2009-12-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077471-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2009-12-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077471-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2009-12-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077471-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2009-12-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077471-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2009-12-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077471-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2009-12-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077471-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2009-12-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077471-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	2009-12-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077471-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	2009-12-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077471-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	2009-12-09	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077471-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077471-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077471-003	AB	1	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	A077471-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077471-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077471-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077471-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077471-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077471-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077471-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077471-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077471-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077471-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077471-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077471-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077471-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077471-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077471-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077471-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077471-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077471-003	AB	1	`ea99ee380514…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52959-413-02	2020-01-31	C162847	48780-1	9d75b9d0-dc0f-f424-e053-dadaa90a57ce	HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mg
52959-413-60	2020-01-31	C162847	48780-1	9d75b9d0-dc0f-f424-e053-dadaa90a57ce	HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-413-02	Hydromorphone Hydrochloride	120 in 1 BOTTLE, PLASTIC	TABLET	120		2
52959-413-60	Hydromorphone Hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-413-02	EA - Each	52959-413	bbc8b4f4-12a8-4903-ac6a-509bd7b80c11	1	2012-07-24
52959-413-60	EA - Each	52959-413	1224bd21-f60c-4b97-ab72-b6e84815135b	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 [H.J. HARKINS COMPANY, INC.]	2
Hydromorphone	ACTIVE MOIETY	Q812464R06	HYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
Anhydrous Lactose	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	HYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-413	HYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2	Legacy NDC, 2 package rows	20111209_7c122909-cedb-469a-99de-a44bcd51238d.zip

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
897696	HYDROmorphone HCl 2 MG Oral Tablet	PSN	7c122909-cedb-469a-99de-a44bcd51238d	2
897702	HYDROmorphone HCl 4 MG Oral Tablet	PSN	7c122909-cedb-469a-99de-a44bcd51238d	2
897710	HYDROmorphone HCl 8 MG Oral Tablet	PSN	7c122909-cedb-469a-99de-a44bcd51238d	2
897696	hydromorphone hydrochloride 2 MG Oral Tablet	SCD	7c122909-cedb-469a-99de-a44bcd51238d	2
897702	hydromorphone hydrochloride 4 MG Oral Tablet	SCD	7c122909-cedb-469a-99de-a44bcd51238d	2
897710	hydromorphone hydrochloride 8 MG Oral Tablet	SCD	7c122909-cedb-469a-99de-a44bcd51238d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-413-02	52959041302	120 in 1 BOTTLE, PLASTIC	Historical
52959-413-60	52959041360	60 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mg	H.J. Harkins Company, Inc. \| Lannett Company, Inc.	2011-12-08	HUMAN PRESCRIPTION DRUG LABEL	2