Home NDC 16110-501-01 Acticlate
Product NDC 16110-501
Requested package NDC 16110-501-01
11-digit product format 161100501
Labeler code 16110
Product ID 16110-501_6655b5f0-f3b7-11eb-85b4-0800200c9a66
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doxycycline hyclate
Dosage form TABLET, COATED
Route ORAL
Labeler Almirall, LLC
Application NDA205931
Marketing category NDA
Marketing start 2014-07-28
Marketing end 0000-00-00
Substance DOXYCYCLINE HYCLATE
Active strength 75 mg/1
Pharmacologic classes Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N205931-001 ACTICLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 N205931-002 ACTICLATE DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205931-001 ACTICLATE EQ 75MG BASE TABLET / ORAL AB RLD 2014-07-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N205931-002 ACTICLATE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2014-07-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXYCYCLINE HYCLATE ACTIVE INGREDIENT 19XTS3T51U ACTICLATE (DOXYCYCLINE HYCLATE) TABLET, COATED [AQUA PHARMACEUTICALS] 2 DOXYCYCLINE ANHYDROUS ACTIVE MOIETY 334895S862 ACTICLATE (DOXYCYCLINE HYCLATE) TABLET, COATED [AQUA PHARMACEUTICALS] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACTICLATE (DOXYCYCLINE HYCLATE) TABLET, COATED [AQUA PHARMACEUTICALS] 2 CROSCARMELLOSE INACTIVE INGREDIENT 029TFK992N ACTICLATE (DOXYCYCLINE HYCLATE) TABLET, COATED [AQUA PHARMACEUTICALS] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ACTICLATE (DOXYCYCLINE HYCLATE) TABLET, COATED [AQUA PHARMACEUTICALS] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ACTICLATE (DOXYCYCLINE HYCLATE) TABLET, COATED [AQUA PHARMACEUTICALS] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ACTICLATE (DOXYCYCLINE HYCLATE) TABLET, COATED [AQUA PHARMACEUTICALS] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ACTICLATE (DOXYCYCLINE HYCLATE) TABLET, COATED [AQUA PHARMACEUTICALS] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACTICLATE (DOXYCYCLINE HYCLATE) TABLET, COATED [AQUA PHARMACEUTICALS] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ACTICLATE (DOXYCYCLINE HYCLATE) TABLET, COATED [AQUA PHARMACEUTICALS] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 ACTICLATE (DOXYCYCLINE HYCLATE) TABLET, COATED [AQUA PHARMACEUTICALS] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ACTICLATE (DOXYCYCLINE HYCLATE) TABLET, COATED [AQUA PHARMACEUTICALS] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U ACTICLATE (DOXYCYCLINE HYCLATE) TABLET, COATED [AQUA PHARMACEUTICALS] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ACTICLATE (DOXYCYCLINE HYCLATE) TABLET, COATED [AQUA PHARMACEUTICALS] 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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 16110-501-01 16110050101 60 TABLET, COATED in 1 BOTTLE (16110-501-01) 2014-07-28 0000-00-00 No No Current