Orphenadrine Citrate, Aspirin and Caffeine

Product NDC
71993-304
11-digit product format
719930304
Labeler code
71993
Product ID
71993-304_414d35d9-b9a2-d717-e063-6294a90a9415
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Orphenadrine Citrate, Aspirin and Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Atland Pharmaceuticals, LLC
Application
ANDA075141
Marketing category
ANDA
Marketing start
2022-03-18
Substance
ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE
Active strength
385; 30; 25 mg/1; mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Centrally-mediated Muscle Relaxation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Muscle Relaxant [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
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, Aspirin and Caffeine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN385 mg/1
CAFFEINE30 mg/1
ORPHENADRINE CITRATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E, 3G6A5W338E, X0A40N8I4S
Rxcui994528

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71993-304-60Orphenadrine Citrate, Aspirin and Caffeine60 in 1 BOTTLE, PLASTICTABLET605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71993-304-60EA - Each71993-304f5cf01c8-69a9-408c-8e98-034ca70cf42212022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71993-304ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE (ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE) TABLET [ATLAND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 1 package rows20241220_61ca2af1-081c-411c-90ce-ec6d9e3157b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994528orphenadrine citrate 25 MG / aspirin 385 MG / caffeine 30 MG Oral TabletPSN61ca2af1-081c-411c-90ce-ec6d9e3157b25
994528aspirin 385 MG / caffeine 30 MG / orphenadrine citrate 25 MG Oral TabletSCD61ca2af1-081c-411c-90ce-ec6d9e3157b25
994528ASA 385 MG / Caffeine 30 MG / Orphenadrine Citrate 25 MG Oral TabletSY61ca2af1-081c-411c-90ce-ec6d9e3157b25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71993-304-607199303046060 TABLET in 1 BOTTLE, PLASTIC (71993-304-60) 60 tablet2022-03-180000-00-00NoNoCurrent