FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
71205-878
11-digit product format
712050878
Labeler code
71205
Product ID
71205-878_a704c66b-9765-4219-868d-36e04628fe23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA214092
Marketing category
ANDA
Marketing start
2021-09-30
Substance
CARBIDOPA; LEVODOPA
Active strength
25; 100 mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carbidopa and Levodopa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA25 mg/1
LEVODOPA100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii46627O600J, MNX7R8C5VO
Rxcui197443, 197444, 197445

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ce6fab2-d006-4589-8ba0-02cee499cc60Product name220260128
ebf3b793-6fcd-797b-9d2e-c3faf6d29442Product name520251106
162160fe-5ea6-4f9d-aa38-c4b780c57046Product name120250515
0e5ae331-9620-4d1f-8061-7c437c7f1c42Product name120250312
028fdaca-77da-0dfe-e445-7dfc440fc97eProduct name420250224
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name720241218
de702a02-e9c0-4daf-9101-e44f2c0d4e66Product name120220609
681917df-580c-4199-896d-b739fbb25ed3Product name120190412
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name420171212
1fa100ae-9ab3-4df0-afe7-33ab01fd4a41Product name120150313
88839c8d-b65b-4a50-997b-4c74539855ffProduct name120150313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-878-00Carbidopa and Levodopa100 in 1 BOTTLE, PLASTICTABLET1002
71205-878-11Carbidopa and Levodopa1000 in 1 BOTTLE, PLASTICTABLET10002
71205-878-30Carbidopa and Levodopa30 in 1 BOTTLE, PLASTICTABLET302
71205-878-55Carbidopa and Levodopa500 in 1 BOTTLE, PLASTICTABLET5002
71205-878-60Carbidopa and Levodopa60 in 1 BOTTLE, PLASTICTABLET602
71205-878-64Carbidopa and Levodopa240 in 1 BOTTLE, PLASTICTABLET2402
71205-878-72Carbidopa and Levodopa120 in 1 BOTTLE, PLASTICTABLET1202
71205-878-78Carbidopa and Levodopa180 in 1 BOTTLE, PLASTICTABLET1802
71205-878-90Carbidopa and Levodopa90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-878-00EA - Each71205-878e0bfccae-4606-4c5c-b9d9-97b98c5d978812021-12-08
71205-878-11EA - Each71205-878fe665b61-b302-466c-bf96-831507b40e9412021-12-08
71205-878-30EA - Each71205-878a8e70df0-a129-45a5-bbe8-9805464b9c0112021-12-08
71205-878-55EA - Each71205-87842b2cd2f-0076-41eb-a119-e7020bc6984212021-12-08
71205-878-60EA - Each71205-878fd7ddf31-6e99-4d0e-a623-6e8db349aecd12021-12-08
71205-878-64EA - Each71205-8785641b414-0486-4765-9af9-87c7ad34882212021-12-08
71205-878-72EA - Each71205-878c776db0b-ebf3-4585-8c5e-5bb27c35fbe412021-12-08
71205-878-78EA - Each71205-878c1ff3396-d3ac-4065-9b3b-8164b0747a4512021-12-08
71205-878-90EA - Each71205-8785a12ea1f-4a38-4862-9e34-4f1e7343a16012021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-878CARBIDOPA AND LEVODOPA TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 9 package rows20220412_0215da3f-13a0-400d-ac2d-20c839bd89ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSN0215da3f-13a0-400d-ac2d-20c839bd89ef2
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN0215da3f-13a0-400d-ac2d-20c839bd89ef2
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN0215da3f-13a0-400d-ac2d-20c839bd89ef2
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCD0215da3f-13a0-400d-ac2d-20c839bd89ef2
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD0215da3f-13a0-400d-ac2d-20c839bd89ef2
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD0215da3f-13a0-400d-ac2d-20c839bd89ef2
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSY0215da3f-13a0-400d-ac2d-20c839bd89ef2
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY0215da3f-13a0-400d-ac2d-20c839bd89ef2
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY0215da3f-13a0-400d-ac2d-20c839bd89ef2
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSY0215da3f-13a0-400d-ac2d-20c839bd89ef2
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY0215da3f-13a0-400d-ac2d-20c839bd89ef2
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY0215da3f-13a0-400d-ac2d-20c839bd89ef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-878-0071205087800100 TABLET in 1 BOTTLE, PLASTIC (71205-878-00) 100 tablet2021-11-050000-00-00NoNoCurrent
71205-878-11712050878111000 TABLET in 1 BOTTLE, PLASTIC (71205-878-11) 1000 tablet2021-11-050000-00-00NoNoCurrent
71205-878-307120508783030 TABLET in 1 BOTTLE, PLASTIC (71205-878-30) 30 tablet2021-11-050000-00-00NoNoCurrent
71205-878-5571205087855500 TABLET in 1 BOTTLE, PLASTIC (71205-878-55) 500 tablet2021-11-050000-00-00NoNoCurrent
71205-878-607120508786060 TABLET in 1 BOTTLE, PLASTIC (71205-878-60) 60 tablet2021-11-050000-00-00NoNoCurrent
71205-878-6471205087864240 TABLET in 1 BOTTLE, PLASTIC (71205-878-64) 240 tablet2021-11-050000-00-00NoNoCurrent
71205-878-7271205087872120 TABLET in 1 BOTTLE, PLASTIC (71205-878-72) 120 tablet2021-11-050000-00-00NoNoCurrent
71205-878-7871205087878180 TABLET in 1 BOTTLE, PLASTIC (71205-878-78) 180 tablet2021-11-050000-00-00NoNoCurrent
71205-878-907120508789090 TABLET in 1 BOTTLE, PLASTIC (71205-878-90) 90 tablet2021-11-050000-00-00NoNoCurrent