Paricalcitol

Product NDC
55111-663
11-digit product format
551110663
Labeler code
55111
Product ID
55111-663_9cdba353-c828-7ee6-0fed-9eb342df7ffc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paricalcitol
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA091412
Marketing category
ANDA
Marketing start
2014-06-25
Substance
PARICALCITOL
Active strength
1 ug/1
Pharmacologic classes
Cholecalciferol [CS], Vitamin D3 Analog [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091412-001PARICALCITOLPARICALCITOL1MCGCAPSULE / ORALAB2014-06-24
A091412-002PARICALCITOLPARICALCITOL2MCGCAPSULE / ORALAB2014-06-24
A091412-003PARICALCITOLPARICALCITOL4MCGCAPSULE / ORALAB2014-06-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A091412-001AB
A091412-002AB
A091412-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091412-001PARICALCITOL1MCGCAPSULE / ORALAB2014-06-24caaa826d4ba7…
2026-08-18 06:07:402026-07A091412-002PARICALCITOL2MCGCAPSULE / ORALAB2014-06-24caaa826d4ba7…
2026-08-18 06:07:402026-07A091412-003PARICALCITOL4MCGCAPSULE / ORALAB2014-06-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091412-001PARICALCITOL1MCGCAPSULE / ORALAB2014-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091412-002PARICALCITOL2MCGCAPSULE / ORALAB2014-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091412-003PARICALCITOL4MCGCAPSULE / ORALAB2014-06-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091412-001PARICALCITOL1MCGCAPSULE / ORALAB2014-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091412-002PARICALCITOL2MCGCAPSULE / ORALAB2014-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091412-003PARICALCITOL4MCGCAPSULE / ORALAB2014-06-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A091412-001PARICALCITOL1MCGCAPSULE / ORALAB2014-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091412-002PARICALCITOL2MCGCAPSULE / ORALAB2014-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091412-003PARICALCITOL4MCGCAPSULE / ORALAB2014-06-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091412-001PARICALCITOL1MCGCAPSULE / ORALAB2014-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091412-002PARICALCITOL2MCGCAPSULE / ORALAB2014-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091412-003PARICALCITOL4MCGCAPSULE / ORALAB2014-06-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091412-001PARICALCITOL1MCGCAPSULE / ORALAB2014-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091412-002PARICALCITOL2MCGCAPSULE / ORALAB2014-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091412-003PARICALCITOL4MCGCAPSULE / ORALAB2014-06-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091412-001PARICALCITOL1MCGCAPSULE / ORALAB2014-06-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091412-002PARICALCITOL2MCGCAPSULE / ORALAB2014-06-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091412-003PARICALCITOL4MCGCAPSULE / ORALAB2014-06-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091412-001PARICALCITOL1MCGCAPSULE / ORALAB2014-06-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091412-002PARICALCITOL2MCGCAPSULE / ORALAB2014-06-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091412-003PARICALCITOL4MCGCAPSULE / ORALAB2014-06-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091412-001PARICALCITOL1MCGCAPSULE / ORALAB2014-06-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091412-002PARICALCITOL2MCGCAPSULE / ORALAB2014-06-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091412-003PARICALCITOL4MCGCAPSULE / ORALAB2014-06-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091412-001PARICALCITOL1MCGCAPSULE / ORALAB2014-06-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091412-002PARICALCITOL2MCGCAPSULE / ORALAB2014-06-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091412-003PARICALCITOL4MCGCAPSULE / ORALAB2014-06-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091412-001PARICALCITOL1MCGCAPSULE / ORALAB2014-06-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A091412-002PARICALCITOL2MCGCAPSULE / ORALAB2014-06-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A091412-003PARICALCITOL4MCGCAPSULE / ORALAB2014-06-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091412-001PARICALCITOL1MCGCAPSULE / ORALAB2014-06-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091412-002PARICALCITOL2MCGCAPSULE / ORALAB2014-06-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091412-003PARICALCITOL4MCGCAPSULE / ORALAB2014-06-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091412-001PARICALCITOL1MCGCAPSULE / ORALAB2014-06-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091412-002PARICALCITOL2MCGCAPSULE / ORALAB2014-06-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091412-003PARICALCITOL4MCGCAPSULE / ORALAB2014-06-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091412-001PARICALCITOL1MCGCAPSULE / ORALAB2014-06-241e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A091412-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091412-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091412-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091412-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091412-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091412-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091412-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091412-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091412-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091412-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091412-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091412-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091412-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091412-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091412-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091412-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091412-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091412-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091412-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091412-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091412-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091412-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091412-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091412-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091412-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091412-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091412-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091412-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091412-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091412-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091412-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091412-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091412-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091412-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091412-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091412-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091412-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091412-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091412-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091412-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Paricalcitol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PARICALCITOL1 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6702D36OG5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
577315Internal RxNorm lookup
577317Internal RxNorm lookup
577324Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aa1a80e9-8778-a03e-5d53-d4b6a6363169Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d92c0b9e-f894-bf80-45eb-73308b7f7f62Product name820190124
3c05259b-d0ee-c435-cb1a-db5d01cf3e37Product name520161206
35d6155d-80a2-4122-bd18-18decc40ac12Product name220150902

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-663-01Paricalcitol100 in 1 BOTTLECAPSULE, LIQUID FILLED1008
55111-663-05Paricalcitol500 in 1 BOTTLECAPSULE, LIQUID FILLED5008
55111-663-30Paricalcitol30 in 1 BOTTLECAPSULE, LIQUID FILLED308
55111-663-79Paricalcitol10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED108
55111-663-81Paricalcitol3 in 1 CARTONCAPSULE, LIQUID FILLED38

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-663-30EA - Each55111-663ddf2a994-5db7-4e29-93b7-ef21abc2102e12014-07-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-663PARICALCITOL CAPSULE, LIQUID FILLED [DR. REDDY'S LABORATORIES LIMITED]8Current NDC, Legacy NDC, 5 package rows20171029_aa1a80e9-8778-a03e-5d53-d4b6a6363169.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
ParicalcitolPARICALCITOLDr. Reddy's Laboratories Limitedaa1a80e9-8778-a03e-5d53-d4b6a63631692017-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091412
application number: ANDA091412
ndc (product): 55111-663

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577315paricalcitol 1 MCG Oral CapsulePSNaa1a80e9-8778-a03e-5d53-d4b6a63631698
577317paricalcitol 2 MCG Oral CapsulePSNaa1a80e9-8778-a03e-5d53-d4b6a63631698
577324paricalcitol 4 MCG Oral CapsulePSNaa1a80e9-8778-a03e-5d53-d4b6a63631698
577315paricalcitol 0.001 MG Oral CapsuleSCDaa1a80e9-8778-a03e-5d53-d4b6a63631698
577317paricalcitol 0.002 MG Oral CapsuleSCDaa1a80e9-8778-a03e-5d53-d4b6a63631698
577324paricalcitol 0.004 MG Oral CapsuleSCDaa1a80e9-8778-a03e-5d53-d4b6a63631698
577315paricalcitol 1 MCG Oral CapsuleSYaa1a80e9-8778-a03e-5d53-d4b6a63631698
577317paricalcitol 2 MCG Oral CapsuleSYaa1a80e9-8778-a03e-5d53-d4b6a63631698
577324paricalcitol 4 MCG Oral CapsuleSYaa1a80e9-8778-a03e-5d53-d4b6a63631698

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-663-0155111066301100 CAPSULE, LIQUID FILLED in 1 BOTTLE (55111-663-01) 2014-06-250000-00-00NoNoCurrent
55111-663-0555111066305500 CAPSULE, LIQUID FILLED in 1 BOTTLE (55111-663-05) 2014-06-250000-00-00NoNoCurrent
55111-663-305511106633030 CAPSULE, LIQUID FILLED in 1 BOTTLE (55111-663-30) 2014-06-250000-00-00NoNoCurrent
55111-663-795511106637910 in 1 BLISTER PACKHistorical
55111-663-81551110663813 BLISTER PACK in 1 CARTON (55111-663-81) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (55111-663-79) 3 blister pack2014-06-250000-00-00NoNoCurrent