HALOG

Product NDC: 64950-127
11-digit product format: 649500127
Labeler code: 64950
Product ID: 64950-127_42dc2391-6bbc-bd57-e063-6294a90a7ef7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Halcinonide Topical
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Genus Lifesciences Inc.
Application: NDA017823
Marketing category: NDA
Marketing start: 2025-11-17
Substance: HALCINONIDE
Active strength: 1 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017823-001	HALOG	HALCINONIDE	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	AT	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017823-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N017823-001	HALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	AT	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017823-001	HALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	AT	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017823-001	HALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	AT	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017823-001	HALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017823-001	HALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017823-001	HALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017823-001	HALOG	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017823-001	HALOG	0.1%	SOLUTION / TOPICAL		RLD, RS, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N017823-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017823-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017823-001	AT	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017823-001	AT	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HALCINONIDE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SI86V6QNEG	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
206550	Internal RxNorm lookup
310669	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
42dc0904-1800-5f3b-e063-6294a90a2ad2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
37520c8a-9139-9e9d-9bd5-8abdb9be6b07	Product name	3	20220311
8582553f-f57a-db33-d781-0d1306d11142	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64950-127-12	HALOG	1 in 1 CARTON	SOLUTION	1		1
64950-127-12	HALOG	120 mL in 1 BOTTLE, PLASTIC	SOLUTION	120		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64950-127-12	ML - Milliliter	64950-127	6ad5470b-c75d-4528-8e93-329d2e2ecafb	1	2025-12-16

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
HALOG	HALCINONIDE TOPICAL	Genus Lifesciences Inc.	42dc0904-1800-5f3b-e063-6294a90a2ad2	2025-11-05	Adverse reactions	Exact identifier application applno (NDA): 017823 application number: NDA017823 ndc (product): 64950-127
HALOG	HALCINONIDE	E.R. Squibb & Sons, L.L.C.	f6c7e87b-6629-4d68-ae46-add64ca9daab	2006-07-06	Adverse reactions	Exact identifier application applno (NDA): 017823 application number: NDA017823

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SI86V6QNEG	HALCINONIDE	3093-35-4	HALCINONIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310669	halcinonide 0.1 % Topical Solution	PSN	42dc0904-1800-5f3b-e063-6294a90a2ad2	1
206550	HALOG SOLUTION 0.1 % Topical Solution	PSN	42dc0904-1800-5f3b-e063-6294a90a2ad2	1
206550	halcinonide 1 MG/ML Topical Solution [Halog]	SBD	42dc0904-1800-5f3b-e063-6294a90a2ad2	1
310669	halcinonide 1 MG/ML Topical Solution	SCD	42dc0904-1800-5f3b-e063-6294a90a2ad2	1
310669	halcinonide 0.1 % Topical Solution	SY	42dc0904-1800-5f3b-e063-6294a90a2ad2	1
206550	Halog 1 MG/ML Topical Solution	SY	42dc0904-1800-5f3b-e063-6294a90a2ad2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
64950-127-12	64950012712	1 BOTTLE, PLASTIC in 1 CARTON (64950-127-12) / 120 mL in 1 BOTTLE, PLASTIC	2025-11-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HALOG	Genus Lifesciences Inc. \| Sun Pharma Canada Inc.	2025-11-05	HUMAN PRESCRIPTION DRUG LABEL	1