Morphine Sulfate

Product NDC: 68000-112
11-digit product format: 680000112
Labeler code: 68000
Product ID: 68000-112_50c61ad1-c1b3-25bc-e063-6394a90a59c5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Morphine Sulfate
Dosage form: SOLUTION
Route: ORAL
Labeler: American Health Packaging
Application: ANDA203518
Marketing category: ANDA
Marketing start: 2026-05-01
Substance: MORPHINE SULFATE
Active strength: 20 mg/mL
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A203518-001	MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL			2015-05-12
A203518-002	MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA		2015-05-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203518-002	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 3 · 88 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
2026-10-15 13:18:30	2026-09	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2015-05-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2015-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2015-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A203518-002	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203518-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203518-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203518-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203518-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203518-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203518-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203518-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203518-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203518-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203518-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203518-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203518-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203518-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203518-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203518-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203518-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203518-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203518-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203518-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203518-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203518-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203518-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203518-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203518-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203518-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203518-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203518-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203518-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203518-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203518-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203518-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203518-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203518-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203518-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203518-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203518-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203518-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203518-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203518-001	AA	1	`bb7c543d1eb4…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MORPHINE SULFATE	20 mg/mL

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
892625	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
5422cdac-8073-41fc-8665-ffe9797f5c02	Available on FDA.report

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	367d508b-3226-42a9-8dc6-f67cdc9979f3	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203518 application number: ANDA203518
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	5422cdac-8073-41fc-8665-ffe9797f5c02	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203518 application number: ANDA203518 ndc (product): 68000-112
Morphine Sulfate	MORPHINE SULFATE	Cranbury Pharmaceuticals, LLC	d8598654-94ad-4cfb-81d2-9b68e013a428	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203518 application number: ANDA203518
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	9bb1fef7-4159-4dca-8a8c-37e53ccc6bab	2024-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203518 application number: ANDA203518
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	b7b86b6d-9a39-494c-bf65-f62e4cdc5807	2023-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203518 application number: ANDA203518

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68000-112-05	68000011205	50 SYRINGE in 1 CARTON (68000-112-05) / .5 mL in 1 SYRINGE (68000-112-06)	50 syringe	2026-05-01	No	No	Current