FDA Orange Book · active-ingredient family
Nicardipine hydrochloride
Nicardipine hydrochloride: 5 brands, 25 generics; first approved Dec 21, 1988; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 25 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
5
Generics (ANDA)
25
Listed patents
6
Next patent expiry
Apr 18, 2027
in 7 mo
Brand (NDA) products
Originator applications
- NICARDIPINE HYDROCHLORIDERLDRSHIKMA INTL PHARMSNDA 02227620083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/10ML (2.5MG/ML) INJECTABLE INJECTION Rx AP 20MG/200ML (0.1MG/ML) INJECTABLE INTRAVENOUS Rx AP 40MG/200ML (0.2MG/ML) INJECTABLE INTRAVENOUS Rx AP - CARDENE SRRLDCHIESINDA 02000519923 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 45MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 60MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - CARDENERLDCHIESINDA 01973419925 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/10ML (2.5MG/ML) INJECTABLE INJECTION Rx AP 20MG/200ML (0.1MG/ML) INJECTABLE INTRAVENOUS Rx — 20MG/200ML (0.1MG/ML) INJECTABLE INTRAVENOUS Rx AP 40MG/200ML (0.2MG/ML) INJECTABLE INTRAVENOUS Rx AP 40MG/200ML (0.2MG/ML) INJECTABLE INTRAVENOUS Discontinued — - CARDENERLDCHIESINDA 01948819882 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG CAPSULE ORAL Discontinued — 30MG CAPSULE ORAL Discontinued — - NICARDIPINE HYDROCHLORIDESUN PHARMNDA 0784052009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/10ML (2.5MG/ML) INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (25)
Abbreviated applications
- FRESENIUS KABI USAANDA 21933420262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/200ML (0.1MG/ML) INJECTABLE INTRAVENOUS Rx AP 40MG/200ML (0.2MG/ML) INJECTABLE INTRAVENOUS Rx AP - NICARDIPINE HYDROCHLORIDEQILU PHARM HAINANANDA 2196082025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/10ML (2.5MG/ML) INJECTABLE INJECTION Rx AP - CAPLINANDA 22024320252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/200ML (0.1MG/ML) INJECTABLE INTRAVENOUS Rx AP 40MG/200ML (0.2MG/ML) INJECTABLE INTRAVENOUS Rx AP - NICARDIPINE HYDROCHLORIDENANJING KING FRIENDANDA 2168192025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/10ML (2.5MG/ML) INJECTABLE INJECTION Rx AP - NICARDIPINE HYDROCHLORIDECHARTWELL RXANDA 21863820252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG CAPSULE ORAL Discontinued — 30MG CAPSULE ORAL Discontinued — - NICARDIPINE HYDROCHLORIDEAMNEALANDA 2154062024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/10ML (2.5MG/ML) INJECTABLE INJECTION Discontinued — - CIPLAANDA 21559220242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/200ML (0.1MG/ML) INJECTABLE INTRAVENOUS Rx AP 40MG/200ML (0.2MG/ML) INJECTABLE INTRAVENOUS Rx AP - NICARDIPINE HYDROCHLORIDECHENGDU SHUODEANDA 2175482024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/10ML (2.5MG/ML) INJECTABLE INJECTION Rx AP - INFORLIFEANDA 20397820242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/200ML (0.1MG/ML) INJECTABLE INTRAVENOUS Rx AP 40MG/200ML (0.2MG/ML) INJECTABLE INTRAVENOUS Rx AP - NICARDIPINE HYDROCHLORIDEAMNEALANDA 21820220242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB - NICARDIPINE HYDROCHLORIDESENORES PHARMSANDA 21537720232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB - NICARDIPINE HYDROCHLORIDEMICRO LABSANDA 2164202023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/10ML (2.5MG/ML) INJECTABLE INJECTION Rx AP - NICARDIPINE HYDROCHLORIDEBIONPHARMAANDA 21755520232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB - NICARDIPINE HYDROCHLORIDEGLENMARK PHARMS LTDANDA 21635720222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB - NICARDIPINE HYDROCHLORIDEEUGIA PHARMAANDA 2111212021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/10ML (2.5MG/ML) INJECTABLE INJECTION Rx AP - NICARDIPINE HYDROCHLORIDEHIKMAANDA 0787142009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/10ML (2.5MG/ML) INJECTABLE INJECTION Discontinued — - NICARDIPINE HYDROCHLORIDERSAM REGENTANDA 0905342009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/10ML (2.5MG/ML) INJECTABLE INJECTION Rx AP - NICARDIPINE HYDROCHLORIDEMANKIND PHARMAANDA 0906712009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/10ML (2.5MG/ML) INJECTABLE INJECTION Rx AP - NICARDIPINE HYDROCHLORIDENAVINTA LLCANDA 0901252009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/10ML (2.5MG/ML) INJECTABLE INJECTION Discontinued — - NICARDIPINE HYDROCHLORIDESOMERSET THERAPS LLCANDA 0906642009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/10ML (2.5MG/ML) INJECTABLE INJECTION Rx AP - NICARDIPINE HYDROCHLORIDEEPIC PHARMA LLCANDA 07492819982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB - NICARDIPINE HYDROCHLORIDEANI PHARMSANDA 07443919962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG CAPSULE ORAL Discontinued — 30MG CAPSULE ORAL Discontinued — - NICARDIPINE HYDROCHLORIDEANI PHARMSANDA 07454019962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG CAPSULE ORAL Discontinued — 30MG CAPSULE ORAL Discontinued — - NICARDIPINE HYDROCHLORIDEANI PHARMSANDA 07467019962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB - NICARDIPINE HYDROCHLORIDEPHARMOBEDIENTANDA 07464219962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG CAPSULE ORAL Discontinued — 30MG CAPSULE ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7659291 | in 7 mo | U-1029 | |
| 11547758 | in 7 mo | U-1029 | |
| 8455524 | in 7 mo | U-1029 | |
| 10758616 | in 7 mo | Product | |
| 9364564 | in 1 yr 4 mo | Product | |
| 7612102 | in 1 yr 4 mo | Product |
Approval history
FDA approval span
First approval
38 yr 3 mo ago
Most recent approval
1 mo ago
Approvals span 1988–2026 across 30 FDA applications.
Brand (NDA) 517%
Generic (ANDA) 2583%
Nicardipine hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
