FDA.reportPublic FDA data

Nicardipine Hydrochloride

Product NDC
70710-2011
11-digit product format
707102011
Labeler code
70710
Product ID
70710-2011_bf108728-380c-41b5-a730-1ddd2c0051ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA218638
Marketing category
ANDA
Marketing start
2025-08-01
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70710-2011DDiscontinued by firm2026-08-17
excluded packagepackage70710-201170710-2011-9DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218638-001NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL2025-06-25
A218638-002NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL2025-06-25

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A218638-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL2025-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07A218638-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL2025-06-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218638-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2025-06-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218638-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2025-06-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218638-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2025-06-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218638-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2025-06-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A218638-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2025-06-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218638-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2025-06-256a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218638-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORAL2025-06-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218638-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORAL2025-06-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218638-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218638-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218638-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218638-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218638-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218638-002AB16a471c1ec25d…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
31746078-c5c3-4387-a2ed-bd3c8b244c53Product name220250325
037c6bd8-1c81-7b8c-8280-c83d993a1f03Product name220250203
c9eb0343-053f-7f78-730f-1be02ab91c6cProduct name520250130

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-2011-9Nicardipine Hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858613niCARdipine HCl 20 MG Oral CapsulePSN861247cc-3edf-4497-b230-2147489548b31
858616niCARdipine HCl 30 MG Oral CapsulePSN861247cc-3edf-4497-b230-2147489548b31
858613nicardipine hydrochloride 20 MG Oral CapsuleSCD861247cc-3edf-4497-b230-2147489548b31
858616nicardipine hydrochloride 30 MG Oral CapsuleSCD861247cc-3edf-4497-b230-2147489548b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-2011-97071020110990 CAPSULE in 1 BOTTLE (70710-2011-9) 90 capsule2025-08-01NoNoHistorical