FDA.reportPublic FDA data

Magnesium Oxide

Product NDC
0603-0213
11-digit product format
006030213
Labeler code
0603
Product ID
0603-0213_02fea0ac-d5c7-47b6-bd7f-df4024e37d3c
Type
HUMAN OTC DRUG
Nonproprietary name
Magnesium Oxide
Dosage form
TABLET
Route
ORAL
Labeler
Endo USA
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-10
Substance
MAGNESIUM OXIDE
Active strength
253 mg/1
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

Additional Listing Data#

Finished product
Yes
Brand name base
Magnesium Oxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM OXIDE253 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3A3U0GI71G
Rxcui311430

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0603-0213-21Magnesium Oxide100 in 1 BOTTLETABLET10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-0213-21EA - Each0603-02134715cc13-8d2e-4aaf-a431-5366461f821312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MAGNESIUM OXIDEACTIVE INGREDIENT3A3U0GI71GMAGNESIUM OXIDE (MAGNESIUM OXIDE) TABLET [QUALITEST PHARMACEUTICALS]1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838MAGNESIUM OXIDE (MAGNESIUM OXIDE) TABLET [QUALITEST PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMAGNESIUM OXIDE (MAGNESIUM OXIDE) TABLET [QUALITEST PHARMACEUTICALS]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MAGNESIUM OXIDE (MAGNESIUM OXIDE) TABLET [QUALITEST PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MAGNESIUM OXIDE (MAGNESIUM OXIDE) TABLET [QUALITEST PHARMACEUTICALS]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMAGNESIUM OXIDE (MAGNESIUM OXIDE) TABLET [QUALITEST PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0603-0213MAGNESIUM OXIDE TABLET [ENDO USA]15Current NDC, Legacy NDC, 1 package rows20241108_d5c123f8-1396-4d8c-96d3-e5ade96a6ef8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311430magnesium oxide 420 MG Oral TabletPSNd5c123f8-1396-4d8c-96d3-e5ade96a6ef815
311430magnesium oxide 420 MG Oral TabletSCDd5c123f8-1396-4d8c-96d3-e5ade96a6ef815
311430magnesium oxide 420 MG (magnesium 253 MG) Oral TabletSYd5c123f8-1396-4d8c-96d3-e5ade96a6ef815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-0213-2100603021321100 TABLET in 1 BOTTLE (0603-0213-21) 100 tablet2020-11-100000-00-00NoNoCurrent