FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
71205-877
11-digit product format
712050877
Labeler code
71205
Product ID
71205-877_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
10; 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
CARBIDOPA10 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
71205-877-00Carbidopa and Levodopa100 in 1 BOTTLE, PLASTICTABLET1002
71205-877-11Carbidopa and Levodopa1000 in 1 BOTTLE, PLASTICTABLET10002
71205-877-30Carbidopa and Levodopa30 in 1 BOTTLE, PLASTICTABLET302
71205-877-55Carbidopa and Levodopa500 in 1 BOTTLE, PLASTICTABLET5002
71205-877-60Carbidopa and Levodopa60 in 1 BOTTLE, PLASTICTABLET602
71205-877-64Carbidopa and Levodopa240 in 1 BOTTLE, PLASTICTABLET2402
71205-877-72Carbidopa and Levodopa120 in 1 BOTTLE, PLASTICTABLET1202
71205-877-78Carbidopa and Levodopa180 in 1 BOTTLE, PLASTICTABLET1802
71205-877-90Carbidopa and Levodopa90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-877-00EA - Each71205-8772ed6e321-dda3-4ed7-a779-30fb75bd9e3212021-12-08
71205-877-11EA - Each71205-877fa6e81d2-aa78-4882-b782-7541bc19501b12021-12-08
71205-877-30EA - Each71205-877376b9d25-54fc-4f0f-bc8f-3bc6ee68d75212021-12-08
71205-877-55EA - Each71205-877c2bd0f31-1856-4e3b-9538-10e22d62b0a012021-12-08
71205-877-60EA - Each71205-8777e3f2eb0-6dff-43fc-879d-21e24a9b412b12021-12-08
71205-877-64EA - Each71205-8776d1c5f11-bd3a-4fd2-9efb-a040bfdd09de12021-12-08
71205-877-72EA - Each71205-877ca7f1d9e-e3f9-475c-bd4a-803fb978435912021-12-08
71205-877-78EA - Each71205-87786add2fa-0ca6-485c-8e41-69cfe390ee2312021-12-08
71205-877-90EA - Each71205-8776f9364b2-09a2-400c-9b04-40c8bc8c1d4912021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-877CARBIDOPA 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
71205-877-0071205087700100 TABLET in 1 BOTTLE, PLASTIC (71205-877-00) 100 tablet2021-11-050000-00-00NoNoCurrent
71205-877-11712050877111000 TABLET in 1 BOTTLE, PLASTIC (71205-877-11) 1000 tablet2021-11-050000-00-00NoNoCurrent
71205-877-307120508773030 TABLET in 1 BOTTLE, PLASTIC (71205-877-30) 30 tablet2021-11-050000-00-00NoNoCurrent
71205-877-5571205087755500 TABLET in 1 BOTTLE, PLASTIC (71205-877-55) 500 tablet2021-11-050000-00-00NoNoCurrent
71205-877-607120508776060 TABLET in 1 BOTTLE, PLASTIC (71205-877-60) 60 tablet2021-11-050000-00-00NoNoCurrent
71205-877-6471205087764240 TABLET in 1 BOTTLE, PLASTIC (71205-877-64) 240 tablet2021-11-050000-00-00NoNoCurrent
71205-877-7271205087772120 TABLET in 1 BOTTLE, PLASTIC (71205-877-72) 120 tablet2021-11-050000-00-00NoNoCurrent
71205-877-7871205087778180 TABLET in 1 BOTTLE, PLASTIC (71205-877-78) 180 tablet2021-11-050000-00-00NoNoCurrent
71205-877-907120508779090 TABLET in 1 BOTTLE, PLASTIC (71205-877-90) 90 tablet2021-11-050000-00-00NoNoCurrent