Normosol-M and Dextrose

Product NDC: 0409-7965
11-digit product format: 004097965
Labeler code: 0409
Product ID: 0409-7965_86cb991a-eca9-4aa2-a93d-6a11e64b709d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, and MAGNESIUM ACETATE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: NDA017610
Marketing category: NDA
Marketing start: 1975-08-13
Marketing end: 2021-05-01
Substance: DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM ACETATE; MAGNESIUM ACETATE
Active strength: 5 g/100mL; mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes: Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0409-7965		D	Discontinued by firm	2026-09-09
excluded product	product	0409-7965		D	Discontinued by firm	2026-09-09
excluded package	package	0409-7965	0409-7965-03	D	Discontinued by firm	2026-09-09
excluded package	package	0409-7965	0409-7965-09	D	Discontinued by firm	2026-09-09
excluded package	package	0409-7965	0409-7965-30	D	Discontinued by firm	2026-09-09
excluded package	package	0409-7965	0409-7965-48	D	Discontinued by firm	2026-09-09

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 · 72 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0409-7965-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0409-7965-48	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0409-7965-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0409-7965-09	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0409-7965-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0409-7965-48	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0409-7965-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0409-7965-09	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0409-7965-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0409-7965-48	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0409-7965-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0409-7965-09	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0409-7965-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0409-7965-48	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0409-7965-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0409-7965-09	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0409-7965-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0409-7965-48	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0409-7965-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0409-7965-09	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0409-7965-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0409-7965-48	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0409-7965-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0409-7965-09	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0409-7965-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0409-7965-48	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0409-7965-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0409-7965-09	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0409-7965-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0409-7965-48	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0409-7965-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0409-7965-09	`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 product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0409-7965-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0409-7965-48	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0409-7965-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0409-7965-09	`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 product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0409-7965-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0409-7965-48	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0409-7965-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0409-7965-09	`ad56d346431e…`	`cc804d4bbf1e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION		Approved before 1982

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017610-001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-7965-03	ML - Milliliter	0409-7965	e040a71e-928a-4a9f-b296-815aafe4e06d	1	2012-07-24
0409-7965-09	ML - Milliliter	0409-7965	e1b5507b-47b1-40cb-8ef1-78c7e3ccbe7f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROSE MONOHYDRATE	ACTIVE INGREDIENT	LX22YL083G	NORMOSOL-M AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATE) INJECTION, SOLUTION [HOSPIRA, INC.]	15
MAGNESIUM ACETATE	ACTIVE INGREDIENT	0E95JZY48K	NORMOSOL-M AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATE) INJECTION, SOLUTION [HOSPIRA, INC.]	15
POTASSIUM ACETATE	ACTIVE INGREDIENT	M911911U02	NORMOSOL-M AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATE) INJECTION, SOLUTION [HOSPIRA, INC.]	15
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	NORMOSOL-M AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATE) INJECTION, SOLUTION [HOSPIRA, INC.]	15
ANHYDROUS DEXTROSE	ACTIVE MOIETY	5SL0G7R0OK	NORMOSOL-M AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATE) INJECTION, SOLUTION [HOSPIRA, INC.]	15
CHLORIDE ION	ACTIVE MOIETY	Q32ZN48698	NORMOSOL-M AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATE) INJECTION, SOLUTION [HOSPIRA, INC.]	15
MAGNESIUM CATION	ACTIVE MOIETY	T6V3LHY838	NORMOSOL-M AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATE) INJECTION, SOLUTION [HOSPIRA, INC.]	15
POTASSIUM CATION	ACTIVE MOIETY	295O53K152	NORMOSOL-M AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATE) INJECTION, SOLUTION [HOSPIRA, INC.]	15
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NORMOSOL-M AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATE) INJECTION, SOLUTION [HOSPIRA, INC.]	15
WATER	INACTIVE INGREDIENT	059QF0KO0R	NORMOSOL-M AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATE) INJECTION, SOLUTION [HOSPIRA, INC.]	15

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
NORMOSOL-M AND DEXTROSE	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATE	ICU Medical Inc.	aba60c84-94d9-46d0-bdbb-25e0c4e8cc41	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017610 application number: NDA017610

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LX22YL083G	DEXTROSE MONOHYDRATE	77938-63-7	DEXTROSE MONOHYDRATE
451W47IQ8X	SODIUM CHLORIDE	7647-14-5	SODIUM CHLORIDE
M911911U02	POTASSIUM ACETATE	127-08-2	POTASSIUM ACETATE
0E95JZY48K	MAGNESIUM ACETATE	142-72-3	MAGNESIUM ACETATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-7965-09	00409796509	12 POUCH in 1 CASE (0409-7965-09) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG	12 pouch	1975-08-13	2021-05-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NORMOSOL TM -M and 5% DEXTROSE Injection MULTIPLE ELECTROLYTES AND 5% DEXTROSE INJECTION TYPE 1, USP	Hospira, Inc.	2020-07-14	HUMAN PRESCRIPTION DRUG LABEL	19