Home NDC 70518-3213-9 Doxycycline Hyclate
Product NDC 70518-3213
Requested package NDC 70518-3213-9
11-digit product format 705183213
Labeler code 70518
Product ID 70518-3213_5cde2fb8-0343-f3e4-e063-6394a90a5014
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline Hyclate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA062677
Marketing category ANDA
Marketing start 2021-09-08
Substance DOXYCYCLINE HYCLATE
Active strength 100 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 44 .
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 A062677-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062677-001 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.
Product history page 1 of 2 · 44 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 2026-10-15 13:18:30 2026-09 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062677-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-07-10 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
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 100 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1650143 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-3213-0 Doxycycline Hyclate 14 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 14 16 70518-3213-1 Doxycycline Hyclate 14 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 14 16 70518-3213-2 Doxycycline Hyclate 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 16 70518-3213-3 Doxycycline Hyclate 2 in 1 BOX TABLET, FILM COATED 2 16 70518-3213-4 Doxycycline Hyclate 1 in 1 POUCH TABLET, FILM COATED 1 16 70518-3213-5 Doxycycline Hyclate 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 16 70518-3213-6 Doxycycline Hyclate 10 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 10 16 70518-3213-7 Doxycycline Hyclate 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 16 70518-3213-8 Doxycycline Hyclate 28 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 28 16 70518-3213-9 Doxycycline Hyclate 56 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 56 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-3213 DOXYCYCLINE HYCLATE TABLET, FILM COATED [REMEDYREPACK INC.] 10 Current NDC, Legacy NDC, 10 package rows 20250502_c8194d6e-c407-465e-a342-4d2d9756dfc4.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Doxycycline Hyclate DOXYCYCLINE HYCLATE PD-Rx Pharmaceuticals, Inc. cf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c 2026-07-29 Warnings, Adverse reactions Exact identifier application applno (ANDA): 062677 application number: ANDA062677 Doxycycline Hyclate DOXYCYCLINE HYCLATE PD-Rx Pharmaceuticals, Inc. 3af9348c-a98b-4059-a5ef-4229e2b33af0 2026-07-20 Warnings, Adverse reactions Exact identifier application applno (ANDA): 062677 application number: ANDA062677 Doxycycline Hyclate DOXYCYCLINE HYCLATE PD-Rx Pharmaceuticals, Inc. 1401d590-0967-4c6b-b52b-a83e9f6df097 2026-07-17 Warnings, Adverse reactions Exact identifier application applno (ANDA): 062677 application number: ANDA062677 Doxycycline Hyclate DOXYCYCLINE HYCLATE Sun Pharmaceutical Industries, Inc. 214a9cfe-a522-4022-81d4-e59f447401fe 2026-06-03 Warnings, Adverse reactions Exact identifier application applno (ANDA): 062677 application number: ANDA062677 Doxycycline Hyclate DOXYCYCLINE HYCLATE AvPAK 53ff9f7e-0db0-c841-d334-4cf31f658828 2025-12-16 Warnings, Adverse reactions Exact identifier application applno (ANDA): 062677 application number: ANDA062677
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70518-3213-9 70518321309 56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3213-9) 2026-05-13 No No Current