Home NDC 46708-388 DOXYCYCLINE HYCLATE
Product NDC 46708-388
11-digit product format 467080388
Labeler code 46708
Product ID 46708-388_8becf01f-63de-4cf3-881e-94d18fe9274c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOXYCYCLINE HYCLATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA211744
Marketing category ANDA
Marketing start 2020-06-30
Substance DOXYCYCLINE HYCLATE
Active strength 150 mg/1
Pharmacologic classes Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A211744-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 A211744-002 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30
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 2 · 74 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 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211744-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2020-06-30 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211744-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2020-06-30 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Additional Listing Data#
Finished product Yes
Brand name base DOXYCYCLINE HYCLATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYCYCLINE HYCLATE 150 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 1649425 Internal RxNorm lookup 1650446 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 46708-388-60 DOXYCYCLINE HYCLATE 60 in 1 BOTTLE TABLET, FILM COATED 60 2 46708-388-91 DOXYCYCLINE HYCLATE 1000 in 1 BOTTLE TABLET, FILM COATED 1000 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-388 DOXYCYCLINE HYCLATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 2 Current NDC, Legacy NDC, 2 package rows 20230202_6e587d8d-1a82-4dfa-acea-88704d408f2f.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 Marketing start Marketing end Sample Exclude flag Status 46708-388-60 46708038860 60 TABLET, FILM COATED in 1 BOTTLE (46708-388-60) 2020-06-30 0000-00-00 No No Current 46708-388-91 46708038891 1000 TABLET, FILM COATED in 1 BOTTLE (46708-388-91) 2020-06-30 0000-00-00 No No Current