Morphine Sulfate

Product NDC: 67296-2122
Requested package NDC: 67296-2122-3
11-digit product format: 672962122
Labeler code: 67296
Product ID: 67296-2122_4698ad93-3bbf-4c47-e063-6394a90a0b67
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Morphine Sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Redpharm Drug
Application: ANDA215194
Marketing category: ANDA
Marketing start: 2023-09-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A215194-001	MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET / ORAL	AB		2023-08-21
A215194-002	MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET / ORAL	AB		2023-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215194-001	AB
A215194-002	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 2 · 44 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
2026-09-14 22:38:34	2026-08	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215194-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2023-08-21	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215194-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2023-08-21	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215194-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215194-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215194-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215194-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215194-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215194-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215194-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215194-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215194-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215194-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215194-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215194-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215194-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215194-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215194-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215194-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215194-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215194-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215194-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215194-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215194-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215194-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215194-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215194-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215194-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215194-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215194-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215194-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215194-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215194-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215194-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215194-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215194-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215194-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215194-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215194-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215194-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215194-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215194-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215194-002	AB	1	`a72a2bbeb626…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Morphine Sulfate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MORPHINE SULFATE	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X3P646A2J0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
892582	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
300b6afd-bac8-32ca-e063-6294a90a12a7	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-2122-6	Morphine Sulfate	6 in 1 BOTTLE	TABLET	6		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-2122	MORPHINE SULFATE TABLET [REDPHARM DRUG]	2	Current NDC, 1 package rows	20250410_300b6afd-bac8-32ca-e063-6294a90a12a7.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate	MORPHINE SULFATE	Redpharm Drug	58476a6b-b54b-5491-e063-6394a90a38c6	2026-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215194 application number: ANDA215194 ndc (package): 67296-2122-3 ndc (product): 67296-2122 ndc11 (package): 67296212203
Morphine Sulfate	MORPHINE SULFATE	SpecGx LLC	8b69f67f-30b3-4982-953e-5a4b87ec6ac6	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215194 application number: ANDA215194
Morphine Sulfate	MORPHINE SULFATE	Redpharm Drug	300b6afd-bac8-32ca-e063-6294a90a12a7	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215194 application number: ANDA215194 ndc (product): 67296-2122

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	300b6afd-bac8-32ca-e063-6294a90a12a7	5
892582	morphine sulfate 15 MG Oral Tablet	SCD	300b6afd-bac8-32ca-e063-6294a90a12a7	5
892582	MS 15 MG Oral Tablet	SY	300b6afd-bac8-32ca-e063-6294a90a12a7	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-2122-3	67296212203	10 TABLET in 1 BOTTLE (67296-2122-3)	10 tablet	2023-09-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Morphine Sulfate	Redpharm Drug	2026-08-05	HUMAN PRESCRIPTION DRUG LABEL	1
Morphine Sulfate	Redpharm Drug	2025-12-23	HUMAN PRESCRIPTION DRUG LABEL	5