Morphine Sulfate

Product NDC: 67296-1753
11-digit product format: 672961753
Labeler code: 67296
Product ID: 67296-1753_1e1cac09-4fc2-9f10-e063-6294a90a6afa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: morphine sulfate
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA210610
Marketing category: ANDA
Marketing start: 2019-07-22
Substance: MORPHINE SULFATE
Active strength: 15 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	67296-1753		I	Inactivated by FDA	2026-08-17
excluded package	package	67296-1753	67296-1753-1	I	Inactivated by FDA	2026-08-17
excluded package	package	67296-1753	67296-1753-6	I	Inactivated by FDA	2026-08-17
excluded package	package	67296-1753	67296-1753-7	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 1 · 16 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
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	67296-1753-6	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-1753-7	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-1753-1	`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	67296-1753-6	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-1753-7	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-1753-1	`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	67296-1753-6	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-1753-7	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-1753-1	`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	67296-1753-6	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-1753-7	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-1753-1	`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
A210610-001	MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET / ORAL	AB		2019-07-22
A210610-002	MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET / ORAL	AB		2019-07-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210610-001	AB
A210610-002	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 · 82 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	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210610-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2019-07-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210610-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2019-07-22	`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	A210610-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210610-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210610-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210610-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210610-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210610-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210610-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210610-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210610-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210610-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210610-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210610-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210610-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210610-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210610-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210610-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210610-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210610-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210610-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210610-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210610-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210610-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210610-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210610-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210610-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210610-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210610-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210610-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210610-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210610-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210610-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210610-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210610-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210610-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210610-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210610-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210610-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210610-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210610-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210610-002	AB	1	`bb7c543d1eb4…`

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, Related label table
NDC	Effective	Related label
67296-1753-1	2024-07-25	Morphine Sulfate IR 15mg tabs
67296-1753-6	2024-07-25	Morphine Sulfate IR 15mg tabs
67296-1753-7	2024-07-25	Morphine Sulfate IR 15mg tabs
67296-1753-1	2024-01-30	Morphine Sulfate IR 15mg tabs
67296-1753-6	2024-01-30	Morphine Sulfate IR 15mg tabs
67296-1753-7	2024-01-30	Morphine Sulfate IR 15mg tabs

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67296-1753-1	Morphine Sulfate	10 in 1 BOTTLE	TABLET	10	11
67296-1753-6	Morphine Sulfate	6 in 1 BOTTLE	TABLET	6	11
67296-1753-7	Morphine Sulfate	12 in 1 BOTTLE	TABLET	12	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1753	MORPHINE SULFATE TABLET [REDPHARM DRUG, INC.]	11	Current NDC, Legacy NDC, 3 package rows	20240727_afd9129b-9d17-d002-e053-2a95a90a39ae.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	Upsher-Smith Laboratories, LLC	5ceb3205-2f8d-4ba3-9f27-dc328bab4fa1	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210610 application number: ANDA210610

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
892582	morphine sulfate 15 MG Oral Tablet	PSN	afd9129b-9d17-d002-e053-2a95a90a39ae	11
892582	morphine sulfate 15 MG Oral Tablet	SCD	afd9129b-9d17-d002-e053-2a95a90a39ae	11
892582	MS 15 MG Oral Tablet	SY	afd9129b-9d17-d002-e053-2a95a90a39ae	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1753-1	67296175301	10 TABLET in 1 BOTTLE (67296-1753-1)	10 tablet	2019-07-22	0000-00-00	No	No	Current
67296-1753-6	67296175306	6 TABLET in 1 BOTTLE (67296-1753-6)	6 tablet	2019-07-22	0000-00-00	No	No	Current
67296-1753-7	67296175307	12 TABLET in 1 BOTTLE (67296-1753-7)	12 tablet	2019-07-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Morphine Sulfate IR 15mg tabs	RedPharm Drug, Inc. \| EPM Packaging	2024-07-25	HUMAN PRESCRIPTION DRUG LABEL	11