FDA.reportPublic FDA data

Methocarbamol

Product NDC
10544-773
11-digit product format
105440773
Labeler code
10544
Product ID
10544-773_23cd352d-9463-4cbe-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA086989
Marketing category
ANDA
Marketing start
2014-01-22
Marketing end
0000-00-00
Substance
METHOCARBAMOL
Active strength
500 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
492965be-47bc-38cf-57c4-5c5e0343abe5Product name620211028
02a01e9c-3f4e-c0ee-6542-be865127aea3Product name820190205

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-773-182020-01-31C16284748780-19d75b9d0-a759-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP
10544-773-202020-01-31C16284748780-19d75b9d0-a759-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP
10544-773-302020-01-31C16284748780-19d75b9d0-a759-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP
10544-773-602020-01-31C16284748780-19d75b9d0-a759-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP
10544-773-902020-01-31C16284748780-19d75b9d0-a759-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-773-18Methocarbamol18 in 1 BOTTLETABLET184
10544-773-20Methocarbamol20 in 1 BOTTLETABLET204
10544-773-30Methocarbamol30 in 1 BOTTLETABLET304
10544-773-60Methocarbamol60 in 1 BOTTLETABLET604
10544-773-90Methocarbamol90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-773-18EA - Each10544-77341deb605-458d-483c-ad62-67211d1c1b4f12015-10-02
10544-773-20EA - Each10544-773adbf23d7-c3de-40e2-8809-0162c0c8e1f812015-10-02
10544-773-30EA - Each10544-773f7683572-16b9-4bd8-af78-e700677bf06512015-10-02
10544-773-60EA - Each10544-773653014a2-a14c-49ab-8aa1-34622765d99912014-08-01
10544-773-90EA - Each10544-77349ef3724-be9d-43e4-b724-066c814161fc12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOCARBAMOLACTIVE INGREDIENT125OD7737XMETHOCARBAMOL TABLET [BLENHEIM PHARMACAL, INC.]4
METHOCARBAMOLACTIVE MOIETY125OD7737XMETHOCARBAMOL TABLET [BLENHEIM PHARMACAL, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHOCARBAMOL TABLET [BLENHEIM PHARMACAL, INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EMETHOCARBAMOL TABLET [BLENHEIM PHARMACAL, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHOCARBAMOL TABLET [BLENHEIM PHARMACAL, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-773METHOCARBAMOL TABLET [BLENHEIM PHARMACAL, INC.]4Legacy NDC, 5 package rows20151105_4cd1701a-c4f2-429a-a4db-185ece4e9a58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN4cd1701a-c4f2-429a-a4db-185ece4e9a584
197944methocarbamol 750 MG Oral TabletPSN4cd1701a-c4f2-429a-a4db-185ece4e9a584
197943methocarbamol 500 MG Oral TabletSCD4cd1701a-c4f2-429a-a4db-185ece4e9a584
197944methocarbamol 750 MG Oral TabletSCD4cd1701a-c4f2-429a-a4db-185ece4e9a584

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-773-181054407731818 in 1 BOTTLEHistorical
10544-773-201054407732020 in 1 BOTTLEHistorical
10544-773-301054407733030 in 1 BOTTLEHistorical
10544-773-601054407736060 in 1 BOTTLEHistorical
10544-773-901054407739090 in 1 BOTTLEHistorical