Pellix

Product NDC: 87143-300
11-digit product format: 871430300
Labeler code: 87143
Product ID: 87143-300_ba4b6a09-9cc9-4617-8c81-b09ecca5fb9e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: calcipotriene
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Perfero Pharma, Inc.
Application: ANDA078468
Marketing category: ANDA
Marketing start: 2026-05-04
Substance: CALCIPOTRIENE
Active strength: .05 mg/mL
Pharmacologic classes: Vitamin D Analog [EPC], Vitamin D [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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078468-001	CALCIPOTRIENE	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078468-001	AT

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2011-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2011-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2011-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2011-03-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2011-03-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2011-03-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2011-03-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2011-03-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2011-03-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2011-03-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2011-03-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2011-03-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2011-03-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	RS	2011-03-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2011-03-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2011-03-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2011-03-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2011-03-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078468-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2011-03-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A078468-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078468-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078468-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078468-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078468-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078468-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078468-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078468-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078468-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078468-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078468-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078468-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078468-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078468-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078468-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078468-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078468-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078468-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078468-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078468-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078468-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078468-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078468-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078468-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078468-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078468-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078468-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078468-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078468-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078468-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078468-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078468-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078468-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078468-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078468-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078468-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078468-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078468-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078468-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078468-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pellix
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CALCIPOTRIENE	.05 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
143NQ3779B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308865	Internal RxNorm lookup
2742555	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
492ea9cf-0117-4d84-a964-9c0121706ed3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bbdc14c7-d940-43b5-a2f7-36c425991f3c	Product name	1	20240320
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
4d1338f1-f50a-5bb5-4946-11534fdee48f	Product name	2	20210527
7fea2046-07a9-4bb6-9409-828ac6f1f6df	Product name	1	20210201
f059f1a2-0e64-4839-9a7f-42687c91a44b	Product name	1	20201007
c148aeb5-688c-9b49-a40f-30a41e3595e4	Product name	2	20180419
07737a91-49bd-c707-82e4-7a6a1660aef6	Product name	2	20150616
6f16fc1e-e77d-460f-8810-a12ca121425c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
87143-300-60	Pellix	60 mL in 1 BOTTLE, PLASTIC	SOLUTION	60		2
87143-300-60	Pellix	1 in 1 CARTON	SOLUTION	1		2

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pellix	CALCIPOTRIENE	Perfero Pharma, Inc.	492ea9cf-0117-4d84-a964-9c0121706ed3	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078468 application number: ANDA078468 ndc (product): 87143-300
Calcipotriene	CALCIPOTRIENE	Cosette Pharmaceuticals, Inc.	21378c25-5622-8bf7-1a8c-b05940a846a0	2022-11-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078468 application number: ANDA078468

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
143NQ3779B	CALCIPOTRIENE	112965-21-6	CALCIPOTRIENE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308865	calcipotriene 0.005 % Topical Solution	PSN	492ea9cf-0117-4d84-a964-9c0121706ed3	2
2742555	Pellix 0.005 % Topical Solution	PSN	492ea9cf-0117-4d84-a964-9c0121706ed3	2
2742555	calcipotriene 0.05 MG/ML Topical Solution [Pellix]	SBD	492ea9cf-0117-4d84-a964-9c0121706ed3	2
308865	calcipotriene 0.05 MG/ML Topical Solution	SCD	492ea9cf-0117-4d84-a964-9c0121706ed3	2
308865	calcipotriene 0.005 % Topical Solution	SY	492ea9cf-0117-4d84-a964-9c0121706ed3	2
2742555	Pellix 0.005 % Topical Solution	SY	492ea9cf-0117-4d84-a964-9c0121706ed3	2
2742555	Pellix 0.05 MG/ML Topical Solution	SY	492ea9cf-0117-4d84-a964-9c0121706ed3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
87143-300-60	87143030060	1 BOTTLE, PLASTIC in 1 CARTON (87143-300-60) / 60 mL in 1 BOTTLE, PLASTIC	2026-05-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pellix™ (calcipotriene) Topical Solution, 0.005% (Scalp Solution)	Perfero Pharma, Inc. \| Cosette Pharmaceuticals NC Laboratories, LLC	2026-05-04	HUMAN PRESCRIPTION DRUG LABEL	2