NICARDIPINE HYDROCHLORIDE

Product NDC
69292-621
11-digit product format
692920621
Labeler code
69292
Product ID
69292-621_3833f906-a53d-44ee-a0a2-17e6bee1d676
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nicardipine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Amici Pharma Inc
Application
ANDA215377
Marketing category
ANDA
Marketing start
2026-01-15
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A215377-001NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-17
A215377-002NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A215377-001AB
A215377-002AB

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
2026-02-19 14:30 UTC2026-02A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-178072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-176a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-171c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-17ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-17a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-179b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-179b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215377-001NICARDIPINE HYDROCHLORIDE20MGCAPSULE / ORALAB2023-07-17a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215377-002NICARDIPINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-07-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215377-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215377-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215377-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215377-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215377-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215377-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215377-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215377-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215377-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215377-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215377-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215377-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215377-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215377-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215377-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215377-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215377-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215377-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215377-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215377-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215377-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215377-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215377-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215377-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215377-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215377-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215377-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215377-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215377-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215377-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215377-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215377-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215377-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215377-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215377-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215377-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215377-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215377-002AB19b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215377-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215377-002AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215377-001CGT2024-03-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215377-002CGT2024-03-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215377-001CGT2024-03-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215377-002CGT2024-03-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215377-001CGT2024-03-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215377-002CGT2024-03-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215377-001CGT2024-03-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215377-002CGT2024-03-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215377-001CGT2024-03-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A215377-002CGT2024-03-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215377-001CGT2024-03-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215377-002CGT2024-03-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215377-001CGT2024-03-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215377-002CGT2024-03-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215377-001CGT2024-03-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215377-002CGT2024-03-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215377-001CGT2024-03-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215377-002CGT2024-03-208072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215377-001CGT2024-03-206a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215377-002CGT2024-03-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215377-001CGT2024-03-201c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215377-002CGT2024-03-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215377-001CGT2024-03-20ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215377-002CGT2024-03-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215377-001CGT2024-03-20a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215377-002CGT2024-03-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215377-001CGT2024-03-209b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215377-002CGT2024-03-209b2671bbb829…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEAmerisyn LLC575c5dab-e832-192a-e063-6294a90a34a12026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215377
application number: ANDA215377
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEAmici Pharma Incedda985c-004e-4487-b856-13cf2cdb900f2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215377
application number: ANDA215377
ndc (product): 69292-621
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEBurel Pharmaceuticals, LLCcb902af0-b5ad-4680-b2f2-007ef2196efe2023-09-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215377
application number: ANDA215377

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICARDIPINE HYDROCHLORIDE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K5BC5011K3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
858613Internal RxNorm lookup
858616Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
edda985c-004e-4487-b856-13cf2cdb900fAvailable on FDA.report

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
69292-621-90NICARDIPINE HYDROCHLORIDE90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69292-621-90EA - Each69292-621148205b8-75d5-44c5-98f9-a2fcd1c0e83112026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858613niCARdipine HCl 20 MG Oral CapsulePSNedda985c-004e-4487-b856-13cf2cdb900f1
858616niCARdipine HCl 30 MG Oral CapsulePSNedda985c-004e-4487-b856-13cf2cdb900f1
858613nicardipine hydrochloride 20 MG Oral CapsuleSCDedda985c-004e-4487-b856-13cf2cdb900f1
858616nicardipine hydrochloride 30 MG Oral CapsuleSCDedda985c-004e-4487-b856-13cf2cdb900f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69292-621-906929206219090 CAPSULE in 1 BOTTLE (69292-621-90) 90 capsule2026-01-15NoNoCurrent