Home NDC 0591-5553-77 Doxycycline Hyclate
Product NDC 0591-5553
Requested package NDC 0591-5553-77
11-digit product format 005915553
Labeler code 0591
Product ID 0591-5553_0fb9a3f8-9ebb-4c21-8a73-9f082b39039c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline Hyclate
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA062421
Marketing category ANDA
Marketing start 1990-01-01
Marketing end 2027-02-28
Substance DOXYCYCLINE HYCLATE
Active strength 100 mg/1
Pharmacologic classes Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag No
Current FDA listing Yes 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 · 11 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 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…
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 A062421-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062421-001 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 · 41 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 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Doxycycline Hyclate 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0591-5553-05 Doxycycline Hyclate 500 in 1 BOTTLE, PLASTIC TABLET 500 33 0591-5553-50 Doxycycline Hyclate 50 in 1 BOTTLE, PLASTIC TABLET 50 33
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXYCYCLINE HYCLATE ACTIVE INGREDIENT 19XTS3T51U DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.] 16 DOXYCYCLINE ANHYDROUS ACTIVE MOIETY 334895S862 DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.] 16 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.] 16 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.] 16 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.] 16 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.] 16 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.] 16 GELATIN INACTIVE INGREDIENT 2G86QN327L DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.] 16 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.] 16 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.] 16 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.] 16 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.] 16 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.] 16 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.] 16 DOXYCYCLINE HYCLATE ACTIVE INGREDIENT 19XTS3T51U DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 DOXYCYCLINE ANHYDROUS ACTIVE MOIETY 334895S862 DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-5553 DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.] 32 Current NDC, Legacy NDC, 2 package rows 20250508_a569ba80-ffea-40b2-9fbe-a42810b1fccb.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 Status 0591-5553-77 00591555377 53340 TABLET in 1 CONTAINER (0591-5553-77) 53340 tablet 19-SEP-24 Current