Home NDC 62135-975 Doxycycline Hyclate
Product NDC 62135-975
11-digit product format 621350975
Labeler code 62135
Product ID 62135-975_557da3d9-d196-9ae5-e063-6394a90a2916
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline Hyclate
Dosage form CAPSULE
Route ORAL
Labeler Chartwell RX, LLC
Application NDA208253
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2016-04-26
Substance DOXYCYCLINE HYCLATE
Active strength 75 mg/1
Pharmacologic classes Tetracycline-class Drug [EPC], Tetracyclines [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 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 N208253-001 ACTICLATE CAP EQ 75MG BASE CAPSULE / ORAL RLD 2016-04-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208253-001 ACTICLATE CAP EQ 75MG BASE CAPSULE / ORAL RLD 2016-04-26 caaa826d4ba7…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Doxycycline Hyclate
Listing expiration 2027-12-31 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1649425 Internal RxNorm lookup 1650446 Internal RxNorm lookup 1791505 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-975-20 Doxycycline Hyclate 20 in 1 BOTTLE CAPSULE 20 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-975 DOXYCYCLINE HYCLATE TABLET, FILM COATED DOXYCYCLINE HYCLATE CAPSULE [CHARTWELL RX, LLC] 1 Current NDC, 1 package rows 20250412_fad03768-f1d2-459f-965e-0ec29f189f1f.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62135-975-20 62135097520 20 CAPSULE in 1 BOTTLE (62135-975-20) 20 capsule 2025-03-26 No No Current