Acticlate

Product NDC: 16110-601
11-digit product format: 161100601
Labeler code: 16110
Product ID: 16110-601_2e463b1b-d30e-4ae6-95c3-853aba0221a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxycycline hyclate
Dosage form: CAPSULE
Route: ORAL
Labeler: Aqua Pharmaceuticals
Application: NDA208253
Marketing category: NDA
Marketing start: 2018-05-31
Substance: DOXYCYCLINE HYCLATE
Active strength: 75 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	16110-601		D	Discontinued by firm		2026-08-10
excluded package	package	16110-601	16110-601-01	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16110-601-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16110-601-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16110-601-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16110-601-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16110-601-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16110-601-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16110-601-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16110-601-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16110-601-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16110-601-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16110-601-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16110-601-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N208253-001	ACTICLATE CAP	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE / ORAL		RLD	2016-04-26

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Acticlate
Brand name suffix: CAP
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYCYCLINE HYCLATE	75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
19XTS3T51U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1791505	Internal RxNorm lookup
1791507	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
5e96d473-63dd-4446-88cf-eef2cd3339f0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b4321c75-2e87-4d90-9726-9a28fb2293a3	Product name	3	20260112
5e99724e-0654-4aec-b7a2-0b9b10e312ee	Product name	3	20250227
d2d36660-68ce-7e7d-0630-ec4b0d859fad	Product name	6	20220921
a239f4dd-cf93-4660-b190-f97d000f249f	Product name	7	20210607
a9d03566-caeb-4466-8021-74599b048880	Product name	3	20210604
12750814-20f7-4f35-b5fa-dbc8811ba858	Product name	9	20201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5ade	Product name	1	20200706
7b4b06ac-8c50-45f0-9556-293ea558a294	Product name	1	20180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84	Product name	5	20171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371	Product name	2	20171115
58b1278c-6dce-49b6-a05e-ea16f389acba	Product name	1	20160620

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16110-601-01	ActiclateCAP	60 in 1 BOTTLE	CAPSULE	60		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16110-601	ACTICLATE CAP (DOXYCYCLINE HYCLATE) CAPSULE [AQUA PHARMACEUTICALS]	2	Current NDC, Legacy NDC, 1 package rows	20180531_5e96d473-63dd-4446-88cf-eef2cd3339f0.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Chartwell RX, LLC	fad03768-f1d2-459f-965e-0ec29f189f1f	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208253 application number: NDA208253
Acticlate CAP	DOXYCYCLINE HYCLATE	Aqua Pharmaceuticals	5e96d473-63dd-4446-88cf-eef2cd3339f0	2017-11-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208253 application number: NDA208253 ndc (product): 16110-601

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19XTS3T51U	DOXYCYCLINE HYCLATE	24390-14-5	DOXYCYCLINE HYCLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1791507	Acticlate 75 MG Oral Capsule	PSN	5e96d473-63dd-4446-88cf-eef2cd3339f0	2
1791505	doxycycline hyclate 75 MG Oral Capsule	PSN	5e96d473-63dd-4446-88cf-eef2cd3339f0	2
1791507	doxycycline hyclate 75 MG Oral Capsule [Acticlate]	SBD	5e96d473-63dd-4446-88cf-eef2cd3339f0	2
1791505	doxycycline hyclate 75 MG Oral Capsule	SCD	5e96d473-63dd-4446-88cf-eef2cd3339f0	2
1791507	Acticlate 75 MG (as doxycycline hyclate 86.6 MG) Oral Capsule	SY	5e96d473-63dd-4446-88cf-eef2cd3339f0	2
1791507	Acticlate 75 MG Oral Capsule	SY	5e96d473-63dd-4446-88cf-eef2cd3339f0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16110-601-01	16110060101	60 CAPSULE in 1 BOTTLE (16110-601-01)	60 capsule	2018-05-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acticlate CAP	Aqua Pharmaceuticals \| Catalent Pharma Solutions, LLC	2017-11-28	HUMAN PRESCRIPTION DRUG LABEL	2