Tretinoin (Microsphere)

Product NDC: 68308-777
11-digit product format: 683080777
Labeler code: 68308
Product ID: 68308-777_7c0103a9-019d-4bc4-b4f5-df7d89bfd11d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tretinoin
Dosage form: GEL
Route: TOPICAL
Labeler: Mayne Pharma
Application: ANDA215609
Marketing category: ANDA
Marketing start: 2024-10-25
Substance: TRETINOIN
Active strength: .8 mg/g
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215609-001	TRETINOIN MICROSPHERE	TRETINOIN	0.08%	GEL / TOPICAL	AB		2023-08-22
A215609-002	TRETINOIN MICROSPHERE	TRETINOIN	0.06%	GEL / TOPICAL	AB		2026-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A215609-001	AB
A215609-002	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.

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	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215609-001	TRETINOIN MICROSPHERE	0.08%	GEL / TOPICAL	AB	2023-08-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215609-002	TRETINOIN MICROSPHERE	0.06%	GEL / TOPICAL	AB	2026-04-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215609-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215609-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215609-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215609-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215609-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215609-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215609-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215609-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215609-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215609-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215609-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215609-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215609-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215609-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215609-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215609-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215609-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215609-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215609-001	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215609-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215609-002	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215609-001	CGT	2024-03-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215609-001	CGT	2024-03-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215609-001	CGT	2024-03-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215609-001	CGT	2024-03-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215609-001	CGT	2024-03-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215609-001	CGT	2024-03-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215609-001	CGT	2024-03-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215609-001	CGT	2024-03-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215609-001	CGT	2024-03-06	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215609-001	CGT	2024-03-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215609-001	CGT	2024-03-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215609-001	CGT	2024-03-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215609-001	CGT	2024-03-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215609-001	CGT	2024-03-06	`9b2671bbb829…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tretinoin (Microsphere)
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRETINOIN	.8 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5688UTC01R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1488045	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
ed2103ee-c9d5-4b3d-b525-318cf67be050	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60	Product name	6	20251124
1426d8f8-b7d5-4053-8554-613df00c0d86	Product name	2	20250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ec	Product name	2	20250521
e3af9708-3004-7392-4046-5311eaa8bab5	Product name	3	20221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06e	Product name	1	20220128
503b047e-e62d-4745-9011-522b13bc701b	Product name	1	20181206
7d41caa2-0b5d-9b03-ab8d-84271de26ef4	Product name	2	20170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572	Product name	2	20150818
0a8118e4-08c6-b395-9ddc-d3e425e0493a	Product name	1	20140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579	Product name	1	20140508
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68308-777-50	Tretinoin (Microsphere)	50 g in 1 BOTTLE, PUMP	GEL	50		1
68308-777-50	Tretinoin (Microsphere)	1 in 1 CARTON	GEL	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68308-777-50	GM - Gram	68308-777	df19074f-0b96-4167-8948-eacff4679cb1	1	2024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68308-777	TRETINOIN (MICROSPHERE) (TRETINOIN) GEL [MAYNE PHARMA]	1	Current NDC, 2 package rows	20241030_ed2103ee-c9d5-4b3d-b525-318cf67be050.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRETINOIN	TRETINOIN	Encube Ethicals, Inc.	57558405-42fa-40bb-a61c-48e030d976de	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215609 application number: ANDA215609
Tretinoin	TRETINOIN	Bryant Ranch Prepack	2b58cf56-e713-4cdd-8b4e-e6651ef76650	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215609 application number: ANDA215609
Tretinoin (Microsphere)	TRETINOIN	Mayne Pharma	ed2103ee-c9d5-4b3d-b525-318cf67be050	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215609 application number: ANDA215609 ndc (product): 68308-777

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5688UTC01R	TRETINOIN	302-79-4	TRETINOIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1488045	tretinoin 0.08 % Topical Gel	PSN	ed2103ee-c9d5-4b3d-b525-318cf67be050	1
1488045	tretinoin 0.0008 MG/MG Topical Gel	SCD	ed2103ee-c9d5-4b3d-b525-318cf67be050	1
1488045	tretinoin 0.08 % Topical Gel	SY	ed2103ee-c9d5-4b3d-b525-318cf67be050	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68308-777-50	68308077750	1 BOTTLE, PUMP in 1 CARTON (68308-777-50) / 50 g in 1 BOTTLE, PUMP	2024-10-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tretinoin (Microsphere)	Mayne Pharma \| Encube Ethicals Private Limited	2024-10-28	HUMAN PRESCRIPTION DRUG LABEL	1