Paricalcitol

Product NDC: 69452-145
11-digit product format: 694520145
Labeler code: 69452
Product ID: 69452-145_0d856fce-7c7d-18e7-e063-6394a90ac945
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Paricalcitol
Dosage form: CAPSULE
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA202539
Marketing category: ANDA
Marketing start: 2016-08-16
Substance: PARICALCITOL
Active strength: 1 ug/1
Pharmacologic classes: Ergocalciferols [CS], Vitamin D Analog [EPC], Vitamin D2 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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202539-001	PARICALCITOL	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27
A202539-002	PARICALCITOL	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27
A202539-003	PARICALCITOL	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202539-001	AB
A202539-002	AB
A202539-003	AB

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202539-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202539-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202539-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202539-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202539-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202539-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202539-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202539-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202539-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202539-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202539-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202539-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202539-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202539-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202539-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202539-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202539-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202539-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202539-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202539-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202539-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202539-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202539-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202539-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202539-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202539-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202539-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202539-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202539-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202539-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202539-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202539-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202539-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202539-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202539-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202539-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202539-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202539-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202539-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202539-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PARICALCITOL	1 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6702D36OG5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
755476e5-62a2-4f01-92a3-307e192ad42c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
d92c0b9e-f894-bf80-45eb-73308b7f7f62	Product name	8	20190124
3c05259b-d0ee-c435-cb1a-db5d01cf3e37	Product name	5	20161206
35d6155d-80a2-4122-bd18-18decc40ac12	Product name	2	20150902

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69452-145-13	Paricalcitol	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69452-145-13	EA - Each	69452-145	1e24d6f2-fa66-47fa-bf4a-f8c4592f52a6	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-145	PARICALCITOL CAPSULE [BIONPHARMA INC.]	5	Current NDC, Legacy NDC, 1 package rows	20231228_755476e5-62a2-4f01-92a3-307e192ad42c.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paricalcitol	PARICALCITOL	Bryant Ranch Prepack	664253fb-d99d-4af6-971b-95c0087406d9	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202539 application number: ANDA202539
Paricalcitol	PARICALCITOL	Bryant Ranch Prepack	22a0d467-9881-458f-8b1c-1186feb96ee4	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202539 application number: ANDA202539
Paricalcitol	PARICALCITOL	Bryant Ranch Prepack	52ca3d88-e85d-44a9-8aa7-eb25a8a73f6f	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202539 application number: ANDA202539
Paricalcitol	PARICALCITOL	Bryant Ranch Prepack	d62d977a-bbfc-454a-a4a9-017a9f525574	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202539 application number: ANDA202539
Paricalcitol	PARICALCITOL	Bionpharma Inc.	755476e5-62a2-4f01-92a3-307e192ad42c	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202539 application number: ANDA202539 ndc (product): 69452-145

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6702D36OG5	PARICALCITOL	131918-61-1	PARICALCITOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
577315	paricalcitol 1 MCG Oral Capsule	PSN	22a0d467-9881-458f-8b1c-1186feb96ee4	105
577315	paricalcitol 0.001 MG Oral Capsule	SCD	22a0d467-9881-458f-8b1c-1186feb96ee4	105
577315	paricalcitol 1 MCG Oral Capsule	SY	22a0d467-9881-458f-8b1c-1186feb96ee4	105
577315	paricalcitol 1 MCG Oral Capsule	PSN	664253fb-d99d-4af6-971b-95c0087406d9	102
577315	paricalcitol 0.001 MG Oral Capsule	SCD	664253fb-d99d-4af6-971b-95c0087406d9	102
577315	paricalcitol 1 MCG Oral Capsule	SY	664253fb-d99d-4af6-971b-95c0087406d9	102
577315	paricalcitol 1 MCG Oral Capsule	PSN	755476e5-62a2-4f01-92a3-307e192ad42c	5
577317	paricalcitol 2 MCG Oral Capsule	PSN	755476e5-62a2-4f01-92a3-307e192ad42c	5
577324	paricalcitol 4 MCG Oral Capsule	PSN	755476e5-62a2-4f01-92a3-307e192ad42c	5
577315	paricalcitol 0.001 MG Oral Capsule	SCD	755476e5-62a2-4f01-92a3-307e192ad42c	5
577317	paricalcitol 0.002 MG Oral Capsule	SCD	755476e5-62a2-4f01-92a3-307e192ad42c	5
577324	paricalcitol 0.004 MG Oral Capsule	SCD	755476e5-62a2-4f01-92a3-307e192ad42c	5
577315	paricalcitol 1 MCG Oral Capsule	SY	755476e5-62a2-4f01-92a3-307e192ad42c	5
577317	paricalcitol 2 MCG Oral Capsule	SY	755476e5-62a2-4f01-92a3-307e192ad42c	5
577324	paricalcitol 4 MCG Oral Capsule	SY	755476e5-62a2-4f01-92a3-307e192ad42c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69452-145-13	69452014513	30 CAPSULE in 1 BOTTLE, PLASTIC (69452-145-13)	30 capsule	2016-08-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Paricalcitol	Bryant Ranch Prepack	2026-04-23	HUMAN PRESCRIPTION DRUG LABEL	102
Paricalcitol	Bryant Ranch Prepack	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL	105
Paricalcitol	Bionpharma Inc. \| Patheon Softgels Inc.	2023-12-27	HUMAN PRESCRIPTION DRUG LABEL	5
Paricalcitol	Golden State Medical Supply, Inc.	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	4