NICARDIPINE HYDROCHLORIDE

Product NDC
69292-620
11-digit product format
692920620
Labeler code
69292
Product ID
69292-620_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
20 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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 69292-620
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 HYDROCHLORIDE20 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
69292-620-90NICARDIPINE HYDROCHLORIDE90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69292-620-90EA - Each69292-6205204ac24-6e34-4838-addc-6910580c259e12026-02-05

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
69292-620-906929206209090 CAPSULE in 1 BOTTLE (69292-620-90) 90 capsule2026-01-15NoNoCurrent