FDA.reportPublic FDA data

CREXONT

Product NDC
64896-969
11-digit product format
648960969
Labeler code
64896
Product ID
64896-969_61f8ee81-fe48-4f07-8c6b-aad4701c7f8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa and levodopa
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
NDA217186
Marketing category
NDA
Marketing start
2024-08-09
Substance
CARBIDOPA HYDRATE; LEVODOPA
Active strength
70; 280 mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217186-001CREXONTCARBIDOPA; LEVODOPA35MG;140MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-07
N217186-002CREXONTCARBIDOPA; LEVODOPA52.5MG;210MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-07
N217186-003CREXONTCARBIDOPA; LEVODOPA70MG;280MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-07
N217186-004CREXONTCARBIDOPA; LEVODOPA87.5MG;350MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2024-08-07

Orange Book patents#

Current patent rows page 1 of 4 · 248 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217186-001100988452034-10-07U-219Drug product2024-08-12
N217186-001102929352034-10-07U-219Drug product2024-08-12
N217186-001106880582034-10-07U-219Drug product2024-08-12
N217186-001109737692034-10-07U-219Drug product2024-08-12
N217186-001109873132034-10-07U-219Drug product2024-08-12
N217186-001113577332034-10-07Drug product2024-08-12
N217186-001116229412034-10-07Drug product2024-08-12
N217186-001116665382034-10-07U-219Drug product2024-08-12
N217186-001120645212034-10-07Drug product2024-08-21
N217186-001121281412034-10-07U-219Drug product2024-11-13
N217186-001121789182034-10-07Drug product2025-01-08
N217186-001121789192034-10-07U-219Drug product2025-01-08
N217186-001122747932034-10-07Drug product2025-05-06
N217186-001123036052034-10-07Drug product2025-06-12
N217186-001124030992034-10-07Drug product2025-09-29
N217186-001124911642034-10-07Drug product2026-01-07
N217186-001126910742034-10-07Drug product2026-07-30
N217186-001119864492041-12-21U-2192024-08-12
N217186-001121091852041-12-21U-16492024-10-11
N217186-001121091852041-12-21U-2192024-10-11
N217186-001121091852041-12-21U-40042024-10-11
N217186-001121091852041-12-21U-40052024-10-11
N217186-001121941502041-12-21U-2192025-01-22
N217186-001122015962041-12-21U-16492025-02-05
N217186-001122015962041-12-21U-40042025-02-05
N217186-001122015962041-12-21U-40052025-02-05
N217186-001122631482041-12-21U-16492025-04-17
N217186-001122631482041-12-21U-2192025-04-17
N217186-001122631482041-12-21U-40042025-04-17
N217186-001122631482041-12-21U-40052025-04-17
N217186-001122631492041-12-21U-16492025-04-17
N217186-001122631492041-12-21U-2192025-04-17
N217186-001122631492041-12-21U-40042025-04-17
N217186-001122631492041-12-21U-40052025-04-17
N217186-001122959312041-12-21U-16492025-06-12
N217186-001122959312041-12-21U-2192025-06-12
N217186-001122959312041-12-21U-40042025-06-12
N217186-001122959312041-12-21U-40052025-06-12
N217186-001123034812041-12-21U-16492025-06-20
N217186-001123034812041-12-21U-2192025-06-20
N217186-001123034812041-12-21U-40042025-06-20
N217186-001123034812041-12-21U-40052025-06-20
N217186-001123034822041-12-21U-16492025-06-12
N217186-001123034822041-12-21U-2192025-06-12
N217186-001123034822041-12-21U-40042025-06-12
N217186-001123034822041-12-21U-40052025-06-12
N217186-001123701632041-12-21U-16492025-08-25
N217186-001123701632041-12-21U-2192025-08-25
N217186-001123701632041-12-21U-40042025-08-25
N217186-001123701632041-12-21U-40052025-08-25
N217186-001124471392041-12-21U-16492025-11-13
N217186-001124471392041-12-21U-2192025-11-13
N217186-001124471392041-12-21U-40042025-11-13
N217186-001124471392041-12-21U-40052025-11-13
N217186-001124537102041-12-21U-16492025-11-13
N217186-001124537102041-12-21U-2192025-11-13
N217186-001124537102041-12-21U-40042025-11-13
N217186-001124537102041-12-21U-40052025-11-13
N217186-001124586162041-12-21U-16492025-11-18
N217186-001124586162041-12-21U-2192025-11-18
N217186-001124586162041-12-21U-40042025-11-18
N217186-001124586162041-12-21U-40052025-11-18
N217186-002100988452034-10-07U-219Drug product2024-08-12
N217186-002102929352034-10-07U-219Drug product2024-08-12
N217186-002106880582034-10-07U-219Drug product2024-08-12
N217186-002109737692034-10-07U-219Drug product2024-08-12
N217186-002109873132034-10-07U-219Drug product2024-08-12
N217186-002113577332034-10-07Drug product2024-08-12
N217186-002116229412034-10-07Drug product2024-08-12
N217186-002116665382034-10-07U-219Drug product2024-08-12
N217186-002120645212034-10-07Drug product2024-08-21
N217186-002121281412034-10-07U-219Drug product2024-11-13
N217186-002121789182034-10-07Drug product2025-01-08
N217186-002121789192034-10-07U-219Drug product2025-01-08
N217186-002122747932034-10-07Drug product2025-05-06
N217186-002123036052034-10-07Drug product2025-06-12
N217186-002124030992034-10-07Drug product2025-09-29
N217186-002124911642034-10-07Drug product2026-01-07
N217186-002126910742034-10-07Drug product2026-07-30
N217186-002119864492041-12-21U-2192024-08-12

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217186-001NP2027-08-07
N217186-002NP2027-08-07
N217186-003NP2027-08-07
N217186-004NP2027-08-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N217186-001CREXONT35MG;140MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-0784e616aacf4f…
2026-09-14 22:38:342026-08N217186-002CREXONT52.5MG;210MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-0784e616aacf4f…
2026-09-14 22:38:342026-08N217186-003CREXONT70MG;280MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-0784e616aacf4f…
2026-09-14 22:38:342026-08N217186-004CREXONT87.5MG;350MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2024-08-0784e616aacf4f…
2026-08-18 06:07:402026-07N217186-001CREXONT35MG;140MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217186-002CREXONT52.5MG;210MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217186-003CREXONT70MG;280MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217186-004CREXONT87.5MG;350MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2024-08-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217186-001CREXONT35MG;140MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217186-002CREXONT52.5MG;210MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217186-003CREXONT70MG;280MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217186-004CREXONT87.5MG;350MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2024-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217186-001CREXONT35MG;140MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217186-002CREXONT52.5MG;210MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217186-003CREXONT70MG;280MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217186-004CREXONT87.5MG;350MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2024-08-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N217186-001CREXONT35MG;140MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217186-002CREXONT52.5MG;210MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217186-003CREXONT70MG;280MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217186-004CREXONT87.5MG;350MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2024-08-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217186-001CREXONT35MG;140MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217186-002CREXONT52.5MG;210MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217186-003CREXONT70MG;280MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217186-004CREXONT87.5MG;350MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2024-08-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217186-001CREXONT35MG;140MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217186-002CREXONT52.5MG;210MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217186-003CREXONT70MG;280MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217186-004CREXONT87.5MG;350MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2024-08-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217186-001CREXONT35MG;140MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217186-002CREXONT52.5MG;210MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217186-003CREXONT70MG;280MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217186-004CREXONT87.5MG;350MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2024-08-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217186-001CREXONT35MG;140MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217186-002CREXONT52.5MG;210MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217186-003CREXONT70MG;280MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217186-004CREXONT87.5MG;350MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2024-08-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217186-001CREXONT35MG;140MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217186-002CREXONT52.5MG;210MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217186-003CREXONT70MG;280MGCAPSULE, EXTENDED RELEASE / ORALRLD2024-08-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217186-004CREXONT87.5MG;350MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2024-08-075bbf6a4d5a75…

Observed Orange Book patent history#

Patent history page 1 of 46 · 1,828 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N217186-001100988452034-10-07U-219Drug product2024-08-1284e616aacf4f…
2026-09-14 22:38:342026-08N217186-001102929352034-10-07U-219Drug product2024-08-1284e616aacf4f…
2026-09-14 22:38:342026-08N217186-001106880582034-10-07U-219Drug product2024-08-1284e616aacf4f…
2026-09-14 22:38:342026-08N217186-001109737692034-10-07U-219Drug product2024-08-1284e616aacf4f…
2026-09-14 22:38:342026-08N217186-001109873132034-10-07U-219Drug product2024-08-1284e616aacf4f…
2026-09-14 22:38:342026-08N217186-001113577332034-10-07Drug product2024-08-1284e616aacf4f…
2026-09-14 22:38:342026-08N217186-001116229412034-10-07Drug product2024-08-1284e616aacf4f…
2026-09-14 22:38:342026-08N217186-001116665382034-10-07U-219Drug product2024-08-1284e616aacf4f…
2026-09-14 22:38:342026-08N217186-001120645212034-10-07Drug product2024-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N217186-001121281412034-10-07U-219Drug product2024-11-1384e616aacf4f…
2026-09-14 22:38:342026-08N217186-001121789182034-10-07Drug product2025-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N217186-001121789192034-10-07U-219Drug product2025-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N217186-001122747932034-10-07Drug product2025-05-0684e616aacf4f…
2026-09-14 22:38:342026-08N217186-001123036052034-10-07Drug product2025-06-1284e616aacf4f…
2026-09-14 22:38:342026-08N217186-001124030992034-10-07Drug product2025-09-2984e616aacf4f…
2026-09-14 22:38:342026-08N217186-001124911642034-10-07Drug product2026-01-0784e616aacf4f…
2026-09-14 22:38:342026-08N217186-001126910742034-10-07Drug product2026-07-3084e616aacf4f…
2026-09-14 22:38:342026-08N217186-001119864492041-12-21U-2192024-08-1284e616aacf4f…
2026-09-14 22:38:342026-08N217186-001121091852041-12-21U-16492024-10-1184e616aacf4f…
2026-09-14 22:38:342026-08N217186-001121091852041-12-21U-2192024-10-1184e616aacf4f…
2026-09-14 22:38:342026-08N217186-001121091852041-12-21U-40042024-10-1184e616aacf4f…
2026-09-14 22:38:342026-08N217186-001121091852041-12-21U-40052024-10-1184e616aacf4f…
2026-09-14 22:38:342026-08N217186-001121941502041-12-21U-2192025-01-2284e616aacf4f…
2026-09-14 22:38:342026-08N217186-001122015962041-12-21U-16492025-02-0584e616aacf4f…
2026-09-14 22:38:342026-08N217186-001122015962041-12-21U-40042025-02-0584e616aacf4f…
2026-09-14 22:38:342026-08N217186-001122015962041-12-21U-40052025-02-0584e616aacf4f…
2026-09-14 22:38:342026-08N217186-001122631482041-12-21U-16492025-04-1784e616aacf4f…
2026-09-14 22:38:342026-08N217186-001122631482041-12-21U-40042025-04-1784e616aacf4f…
2026-09-14 22:38:342026-08N217186-001122631482041-12-21U-2192025-04-1784e616aacf4f…
2026-09-14 22:38:342026-08N217186-001122631482041-12-21U-40052025-04-1784e616aacf4f…
2026-09-14 22:38:342026-08N217186-001122631492041-12-21U-16492025-04-1784e616aacf4f…
2026-09-14 22:38:342026-08N217186-001122631492041-12-21U-2192025-04-1784e616aacf4f…
2026-09-14 22:38:342026-08N217186-001122631492041-12-21U-40042025-04-1784e616aacf4f…
2026-09-14 22:38:342026-08N217186-001122631492041-12-21U-40052025-04-1784e616aacf4f…
2026-09-14 22:38:342026-08N217186-001122959312041-12-21U-16492025-06-1284e616aacf4f…
2026-09-14 22:38:342026-08N217186-001122959312041-12-21U-40052025-06-1284e616aacf4f…
2026-09-14 22:38:342026-08N217186-001122959312041-12-21U-40042025-06-1284e616aacf4f…
2026-09-14 22:38:342026-08N217186-001122959312041-12-21U-2192025-06-1284e616aacf4f…
2026-09-14 22:38:342026-08N217186-001123034812041-12-21U-16492025-06-2084e616aacf4f…
2026-09-14 22:38:342026-08N217186-001123034812041-12-21U-2192025-06-2084e616aacf4f…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N217186-001NP2027-08-0784e616aacf4f…
2026-09-14 22:38:342026-08N217186-002NP2027-08-0784e616aacf4f…
2026-09-14 22:38:342026-08N217186-003NP2027-08-0784e616aacf4f…
2026-09-14 22:38:342026-08N217186-004NP2027-08-0784e616aacf4f…
2026-08-18 06:07:402026-07N217186-001NP2027-08-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217186-002NP2027-08-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217186-003NP2027-08-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217186-004NP2027-08-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217186-001NP2027-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217186-002NP2027-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217186-003NP2027-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217186-004NP2027-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217186-001NP2027-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217186-002NP2027-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217186-003NP2027-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217186-004NP2027-08-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N217186-001NP2027-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217186-002NP2027-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217186-003NP2027-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217186-004NP2027-08-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217186-001NP2027-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217186-002NP2027-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217186-003NP2027-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217186-004NP2027-08-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217186-001NP2027-08-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217186-002NP2027-08-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217186-003NP2027-08-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217186-004NP2027-08-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217186-001NP2027-08-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217186-002NP2027-08-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217186-003NP2027-08-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217186-004NP2027-08-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217186-001NP2027-08-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217186-002NP2027-08-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217186-003NP2027-08-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217186-004NP2027-08-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217186-001NP2027-08-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217186-002NP2027-08-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217186-003NP2027-08-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217186-004NP2027-08-075bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
CREXONT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA HYDRATE70 mg/1
LEVODOPA280 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MNX7R8C5VOInternal UNII lookup
46627O600JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2690259Internal RxNorm lookup
2690265Internal RxNorm lookup
2690279Internal RxNorm lookup
2690281Internal RxNorm lookup
2690284Internal RxNorm lookup
2690286Internal RxNorm lookup
2690290Internal RxNorm lookup
2690292Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
095a08b6-b0b8-4f88-b759-67e8b87287a0Available on FDA.report

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
de702a02-e9c0-4daf-9101-e44f2c0d4e66Product name120220609
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
681917df-580c-4199-896d-b739fbb25ed3Product name120190412
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name420171212
1fa100ae-9ab3-4df0-afe7-33ab01fd4a41Product name120150313
88839c8d-b65b-4a50-997b-4c74539855ffProduct name120150313
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64896-969-16CREXONT120 in 1 BOTTLECAPSULE, EXTENDED RELEASE12018
64896-969-16CREXONT1 in 1 CARTONCAPSULE, EXTENDED RELEASE118
64896-969-23CREXONT1 in 1 CARTONCAPSULE, EXTENDED RELEASE118
64896-969-23CREXONT120 in 1 BOTTLECAPSULE, EXTENDED RELEASE12018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64896-969-16EA - Each64896-969c750a259-4722-4313-8163-b36203c0294d12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64896-969CREXONT (CARBIDOPA AND LEVODOPA) CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]14Current NDC, 4 package rows20250523_095a08b6-b0b8-4f88-b759-67e8b87287a0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CREXONTCARBIDOPA AND LEVODOPAAmneal Pharmaceuticals LLC095a08b6-b0b8-4f88-b759-67e8b87287a02026-05-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 217186
application number: NDA217186
ndc (product): 64896-969

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2690259carbidopa 35 MG / levodopa 140 MG Extended Release Oral CapsulePSN095a08b6-b0b8-4f88-b759-67e8b87287a019
2690279carbidopa 52.5 MG / levodopa 210 MG Extended Release Oral CapsulePSN095a08b6-b0b8-4f88-b759-67e8b87287a019
2690284carbidopa 70 MG / levodopa 280 MG Extended Release Oral CapsulePSN095a08b6-b0b8-4f88-b759-67e8b87287a019
2690290carbidopa 87.5 MG / levodopa 350 MG Extended Release Oral CapsulePSN095a08b6-b0b8-4f88-b759-67e8b87287a019
2690265CREXONT 35 MG / 140 MG Extended Release Oral CapsulePSN095a08b6-b0b8-4f88-b759-67e8b87287a019
2690281CREXONT 52.5 MG / 210 MG Extended Release Oral CapsulePSN095a08b6-b0b8-4f88-b759-67e8b87287a019
2690286CREXONT 70 MG / 280 MG Extended Release Oral CapsulePSN095a08b6-b0b8-4f88-b759-67e8b87287a019
2690292CREXONT 87.5 MG / 350 MG Extended Release Oral CapsulePSN095a08b6-b0b8-4f88-b759-67e8b87287a019
2690265carbidopa 35 MG / levodopa 140 MG Extended Release Oral Capsule [Crexont]SBD095a08b6-b0b8-4f88-b759-67e8b87287a019
2690281carbidopa 52.5 MG / levodopa 210 MG Extended Release Oral Capsule [Crexont]SBD095a08b6-b0b8-4f88-b759-67e8b87287a019
2690286carbidopa 70 MG / levodopa 280 MG Extended Release Oral Capsule [Crexont]SBD095a08b6-b0b8-4f88-b759-67e8b87287a019
2690292carbidopa 87.5 MG / levodopa 350 MG Extended Release Oral Capsule [Crexont]SBD095a08b6-b0b8-4f88-b759-67e8b87287a019
2690259carbidopa 35 MG / levodopa 140 MG Extended Release Oral CapsuleSCD095a08b6-b0b8-4f88-b759-67e8b87287a019
2690279carbidopa 52.5 MG / levodopa 210 MG Extended Release Oral CapsuleSCD095a08b6-b0b8-4f88-b759-67e8b87287a019
2690284carbidopa 70 MG / levodopa 280 MG Extended Release Oral CapsuleSCD095a08b6-b0b8-4f88-b759-67e8b87287a019
2690290carbidopa 87.5 MG / levodopa 350 MG Extended Release Oral CapsuleSCD095a08b6-b0b8-4f88-b759-67e8b87287a019
2690259carbidopa 35 MG / L-DOPA 140 MG Extended Release Oral CapsuleSY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690265carbidopa 35 MG / L-DOPA 140 MG Extended Release Oral Capsule [Crexont]SY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690279carbidopa 52.5 MG / L-DOPA 210 MG Extended Release Oral CapsuleSY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690281carbidopa 52.5 MG / L-DOPA 210 MG Extended Release Oral Capsule [Crexont]SY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690284carbidopa 70 MG / L-DOPA 280 MG Extended Release Oral CapsuleSY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690286carbidopa 70 MG / L-DOPA 280 MG Extended Release Oral Capsule [Crexont]SY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690290carbidopa 87.5 MG / L-DOPA 350 MG Extended Release Oral CapsuleSY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690292carbidopa 87.5 MG / L-DOPA 350 MG Extended Release Oral Capsule [Crexont]SY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690265Crexont (carbidopa 35 MG / levodopa 140 MG) Extended Release Oral CapsuleSY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690281Crexont (carbidopa 52.5 MG / levodopa 210 MG) Extended Release Oral CapsuleSY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690286Crexont (carbidopa 70 MG / levodopa 280 MG) Extended Release Oral CapsuleSY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690292Crexont (carbidopa 87.5 MG / levodopa 350 MG) Extended Release Oral CapsuleSY095a08b6-b0b8-4f88-b759-67e8b87287a019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64896-969-16648960969161 BOTTLE in 1 CARTON (64896-969-16) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE1 bottle2024-08-09NoNoCurrent
64896-969-23648960969231 BOTTLE in 1 CARTON (64896-969-23) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE1 bottle2024-08-09YesNoCurrent