FDA.reportPublic FDA data

Orphenadrine Citrate

Product NDC
60760-810
11-digit product format
607600810
Labeler code
60760
Product ID
60760-810_450e6eb7-f49b-296e-e063-6294a90a05a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Orphenadrine Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA040284
Marketing category
ANDA
Marketing start
1998-06-19
Substance
ORPHENADRINE CITRATE
Active strength
100 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Orphenadrine Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ORPHENADRINE CITRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX0A40N8I4S
Rxcui994521

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60760-810-30Orphenadrine Citrate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE307
60760-810-60Orphenadrine Citrate60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-810-30EA - Each60760-81073289571-1e4c-45ef-a52b-98a1ca054ac312017-10-13
60760-810-60EA - Each60760-8106e7f25e2-1cbe-4d2c-a53a-8d1b2595e99312017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-810ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [ST. MARY'S MEDICAL PARK PHARMACY]6Current NDC, Legacy NDC, 2 package rows20231118_59000b66-166e-75d2-e053-2a91aa0af3c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN59000b66-166e-75d2-e053-2a91aa0af3c07
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD59000b66-166e-75d2-e053-2a91aa0af3c07
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY59000b66-166e-75d2-e053-2a91aa0af3c07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-810-306076008103030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-810-30) 1998-06-190000-00-00NoNoCurrent
60760-810-606076008106060 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-810-60) 1998-06-190000-00-00NoNoCurrent