Morphine Sulfate

Product NDC: 66336-502
11-digit product format: 663360502
Labeler code: 66336
Product ID: 66336-502_f7aa7607-6319-4a5e-9a21-3a3e97b2e499
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Morphine Sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Dispensing Solutions, Inc.
Application: NDA022207
Marketing category: NDA
Marketing start: 2008-03-17
Marketing end: 0000-00-00
Substance: MORPHINE SULFATE
Active strength: 30 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66336-502		I	Inactivated by FDA	2026-08-17
excluded package	package	66336-502	66336-502-30	I	Inactivated by FDA	2026-08-17
excluded package	package	66336-502	66336-502-60	I	Inactivated by FDA	2026-08-17
excluded package	package	66336-502	66336-502-90	I	Inactivated by FDA	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 2 · 88 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	66336-502-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66336-502-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66336-502-60	`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	66336-502-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66336-502-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66336-502-60	`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	66336-502-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66336-502-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66336-502-60	`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	66336-502-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66336-502-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66336-502-60	`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	66336-502-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66336-502-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66336-502-60	`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	66336-502-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66336-502-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66336-502-60	`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	66336-502-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66336-502-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66336-502-60	`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	66336-502-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66336-502-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66336-502-60	`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	66336-502-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66336-502-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66336-502-60	`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	66336-502-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66336-502-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66336-502-60	`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	66336-502-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66336-502-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66336-502-60	`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	66336-502-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66336-502-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66336-502-60	`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	66336-502-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66336-502-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66336-502-60	`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	66336-502-90	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66336-502-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66336-502-60	`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	66336-502-90	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66336-502-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66336-502-60	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022207-001	MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17
N022207-002	MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022207-001	AB
N022207-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022207-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	RLD	2008-03-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022207-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	RLD, RS	2008-03-17	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N022207-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022207-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022207-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022207-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022207-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022207-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022207-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022207-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022207-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022207-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022207-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022207-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022207-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022207-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022207-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022207-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022207-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022207-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022207-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022207-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022207-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022207-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022207-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022207-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022207-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022207-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022207-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022207-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022207-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022207-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022207-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022207-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022207-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022207-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022207-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022207-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022207-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022207-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022207-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022207-002	AB	1	`bb7c543d1eb4…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022207-001	NPP	2024-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022207-002	NPP	2024-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022207-001	NPP	2024-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022207-002	NPP	2024-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022207-001	NPP	2024-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022207-002	NPP	2024-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022207-001	NPP	2024-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022207-002	NPP	2024-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022207-001	NPP	2024-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022207-002	NPP	2024-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022207-001	NPP	2024-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022207-002	NPP	2024-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022207-001	NPP	2024-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022207-002	NPP	2024-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022207-001	NPP	2024-06-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022207-002	NPP	2024-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022207-001	NPP	2024-06-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022207-002	NPP	2024-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022207-001	NPP	2024-06-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022207-002	NPP	2024-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022207-001	NPP	2024-06-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022207-002	NPP	2024-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022207-001	NPP	2024-06-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022207-002	NPP	2024-06-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022207-001	NPP	2024-06-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022207-002	NPP	2024-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022207-001	NPP	2024-06-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022207-002	NPP	2024-06-02	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022207-001	NPP	2024-06-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022207-002	NPP	2024-06-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022207-001	NPP	2024-06-02	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022207-002	NPP	2024-06-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022207-001	NPP	2024-06-02	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022207-002	NPP	2024-06-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022207-001	NPP	2024-06-02	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022207-002	NPP	2024-06-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022207-001	NPP	2024-06-02	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022207-002	NPP	2024-06-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022207-001	NPP	2024-06-02	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022207-002	NPP	2024-06-02	`a67488948f0b…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
89941d4c-522d-cee0-b273-43cfa7ef6d35	Product name	4	20250516
f15f9e76-db42-8a50-218a-5ef5affa58da	Product name	4	20240216
944b0689-73f4-6a2f-c654-1180896353c0	Product name	4	20220210
67e166c6-23d4-4709-b77d-5ca6182dcae0	Product name	1	20180830
c573a64c-fe17-2eac-fbcb-788868b4ff6b	Product name	9	20180619
7c1819cf-69a0-41dc-aeaa-a820729bc959	Product name	1	20170406
7a68fc31-10e5-df04-67e0-3a613a2d4d2e	Product name	5	20161114
175682a8-c657-45a2-9dfb-c565306b03c8	Product name	1	20160112
b73dadd0-1b4a-4f88-956f-a2be216c8fad	Product name	1	20151123
4c272b1c-87fc-ebc0-994d-ac28b1e0416e	Product name	1	20140508
7a537f54-d322-5e54-a3a2-035d3e21c3c6	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66336-502-30	2019-11-27	C162847	48780-1	9855d018-e093-cd31-e053-dbdaa90ab51a	These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate Tablets, CII Initial U.S. Approval: 1984
66336-502-60	2019-11-27	C162847	48780-1	9855d018-e093-cd31-e053-dbdaa90ab51a	These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate Tablets, CII Initial U.S. Approval: 1984
66336-502-90	2019-11-27	C162847	48780-1	9855d018-e093-cd31-e053-dbdaa90ab51a	These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate Tablets, CII Initial U.S. Approval: 1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66336-502-30	Morphine Sulfate	30 in 1 BOTTLE, PLASTIC	TABLET	30	1
66336-502-60	Morphine Sulfate	60 in 1 BOTTLE, PLASTIC	TABLET	60	1
66336-502-90	Morphine Sulfate	90 in 1 BOTTLE, PLASTIC	TABLET	90	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MORPHINE SULFATE	ACTIVE INGREDIENT	X3P646A2J0	MORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]	1
MORPHINE	ACTIVE MOIETY	76I7G6D29C	MORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66336-502	MORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]	1	Legacy NDC, 3 package rows	20130408_67b3273e-af71-4dac-8e49-8bc134d4c591.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
Morphine Sulfate	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	3c847554-3b4b-4d24-a145-2ef7e9b83699	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022207 application number: NDA022207

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X3P646A2J0	MORPHINE SULFATE	6211-15-0	MORPHINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
892672	morphine sulfate 30 MG Oral Tablet	PSN	67b3273e-af71-4dac-8e49-8bc134d4c591	1
892672	morphine sulfate 30 MG Oral Tablet	SCD	67b3273e-af71-4dac-8e49-8bc134d4c591	1
892672	MS 30 MG Oral Tablet	SY	67b3273e-af71-4dac-8e49-8bc134d4c591	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
66336-502-30	66336050230	30 in 1 BOTTLE, PLASTIC	Historical
66336-502-60	66336050260	60 in 1 BOTTLE, PLASTIC	Historical
66336-502-90	66336050290	90 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Morphine Sulfate	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-04-08	HUMAN PRESCRIPTION DRUG LABEL	1