Magnesium Sulfate in Water

Product NDC: 83634-500
11-digit product format: 836340500
Labeler code: 83634
Product ID: 83634-500_74a0488c-befd-4f6b-af07-d06834e8202a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: magnesium sulfate in water
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Avenacy, LLC
Application: ANDA209642
Marketing category: ANDA
Marketing start: 2024-04-22
Substance: MAGNESIUM SULFATE HEPTAHYDRATE
Active strength: 40 mg/mL
Pharmacologic classes: Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
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 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	TE codes	Approval date
A209642-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08
A209642-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08
A209642-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A209642-001	AP
A209642-002	AP
A209642-003	AP

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 · 99 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
2026-02-19 14:30 UTC	2026-02	A209642-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209642-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209642-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209642-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209642-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209642-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209642-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209642-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209642-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209642-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209642-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209642-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209642-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209642-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209642-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209642-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209642-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209642-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209642-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209642-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209642-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209642-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209642-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209642-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209642-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209642-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209642-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209642-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209642-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209642-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209642-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209642-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209642-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209642-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209642-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209642-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209642-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209642-002	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/100ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209642-003	MAGNESIUM SULFATE IN PLASTIC CONTAINER	4GM/50ML (80MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209642-001	MAGNESIUM SULFATE IN PLASTIC CONTAINER	2GM/50ML (40MG/ML)	INJECTABLE / INJECTION	AP	2021-11-08	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209642-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209642-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209642-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209642-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209642-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209642-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209642-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209642-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209642-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209642-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209642-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209642-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209642-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209642-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209642-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209642-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209642-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209642-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209642-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209642-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209642-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209642-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209642-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209642-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209642-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209642-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209642-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209642-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209642-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209642-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209642-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209642-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209642-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209642-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209642-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209642-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209642-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209642-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209642-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209642-001	AP	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Magnesium Sulfate in Water
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MAGNESIUM SULFATE HEPTAHYDRATE	40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SK47B8698T	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
829734	Internal RxNorm lookup
1658259	Internal RxNorm lookup
1658262	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
f50f4e06-288c-4b5e-9260-f3fe0a210c0c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
83634-500-41	Magnesium Sulfate in Water	50 mL in 1 BAG	INJECTION, SOLUTION	50	4
83634-500-41	Magnesium Sulfate in Water	1 in 1 POUCH	INJECTION, SOLUTION	1	4
83634-500-42	Magnesium Sulfate in Water	1 in 1 POUCH	INJECTION, SOLUTION	1	4
83634-500-42	Magnesium Sulfate in Water	100 mL in 1 BAG	INJECTION, SOLUTION	100	4
83634-500-81	Magnesium Sulfate in Water	24 in 1 CARTON	INJECTION, SOLUTION	24	4
83634-500-82	Magnesium Sulfate in Water	24 in 1 CARTON	INJECTION, SOLUTION	24	4
83634-500-83	Magnesium Sulfate in Water	30 in 1 CARTON	INJECTION, SOLUTION	30	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83634-500-41	ML - Milliliter	83634-500	135a3f55-e373-40e3-bdf8-869c0f5f6262	1	2025-08-11
83634-500-42	ML - Milliliter	83634-500	6406088f-4947-4158-8299-fabc8585b68b	1	2025-07-08
83634-500-81	ML - Milliliter	83634-500	032daf50-ade1-4407-a6de-4c39da77dfc3	1	2024-05-16
83634-500-82	ML - Milliliter	83634-500	f17d64ad-3af6-4d37-bb61-f1f549afe1ee	1	2024-05-16
83634-500-83	ML - Milliliter	83634-500	a23940f0-7843-4c54-9725-b8c9c78d530c	1	2026-05-22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83634-500	MAGNESIUM SULFATE IN WATER INJECTION, SOLUTION [AVENACY INC.]	3	Current NDC, 7 package rows	20241115_f50f4e06-288c-4b5e-9260-f3fe0a210c0c.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Avenacy, LLC	f50f4e06-288c-4b5e-9260-f3fe0a210c0c	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209642 application number: ANDA209642 ndc (product): 83634-500
Magnesium Sulfate in Water	MAGNESIUM SULFATE IN WATER	Athenex Pharmaceutical Division, LLC.	70776952-a340-4405-9cf0-f0988ff8097b	2024-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209642 application number: ANDA209642

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SK47B8698T	MAGNESIUM SULFATE HEPTAHYDRATE	10034-99-8	MAGNESIUM SULFATE HEPTAHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1658259	magnesium sulfate 2 GM in 50 ML Injection	PSN	f50f4e06-288c-4b5e-9260-f3fe0a210c0c	4
1658262	magnesium sulfate 4 GM in 100 ML Injection	PSN	f50f4e06-288c-4b5e-9260-f3fe0a210c0c	4
829734	magnesium sulfate 4 GM in 50 ML Injection	PSN	f50f4e06-288c-4b5e-9260-f3fe0a210c0c	4
1658262	100 ML magnesium sulfate 40 MG/ML Injection	SCD	f50f4e06-288c-4b5e-9260-f3fe0a210c0c	4
1658259	50 ML magnesium sulfate 40 MG/ML Injection	SCD	f50f4e06-288c-4b5e-9260-f3fe0a210c0c	4
829734	50 ML magnesium sulfate 80 MG/ML Injection	SCD	f50f4e06-288c-4b5e-9260-f3fe0a210c0c	4
1658259	magnesium sulfate 2 GM per 50 ML Injection	SY	f50f4e06-288c-4b5e-9260-f3fe0a210c0c	4
1658262	magnesium sulfate 4 GM per 100 ML Injection	SY	f50f4e06-288c-4b5e-9260-f3fe0a210c0c	4
829734	magnesium sulfate 4 GM per 50 ML Injection	SY	f50f4e06-288c-4b5e-9260-f3fe0a210c0c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83634-500-41	83634050041	50 mL in 1 BAG	50 ml				Historical
83634-500-42	83634050042	1 in 1 POUCH					Historical
83634-500-81	83634050081	24 POUCH in 1 CARTON (83634-500-81) / 1 BAG in 1 POUCH (83634-500-41) / 50 mL in 1 BAG	24 pouch	2024-04-22	No	No	Current
83634-500-82	83634050082	24 POUCH in 1 CARTON (83634-500-82) / 1 BAG in 1 POUCH (83634-500-42) / 100 mL in 1 BAG	24 pouch	2024-04-22	No	No	Current
83634-500-83	83634050083	30 POUCH in 1 CARTON (83634-500-83) / 1 BAG in 1 POUCH (83634-500-41) / 50 mL in 1 BAG	30 pouch	2025-09-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Magnesium Sulfate in Water for Injection (For Intravenous Use)	Avenacy, LLC	2025-09-15	HUMAN PRESCRIPTION DRUG LABEL	4