Home NDC 53746-555 Demeclocycline Hydrochloride
Product NDC 53746-555
11-digit product format 537460555
Labeler code 53746
Product ID 53746-555_bd37276e-8e9f-48ec-9565-a83a5a4f9aea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Demeclocycline
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA065425
Marketing category ANDA
Marketing start 2022-05-25
Substance DEMECLOCYCLINE HYDROCHLORIDE
Active strength 300 mg/1
Pharmacologic classes Tetracycline-class Antimicrobial [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 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27
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 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065425-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2008-02-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065425-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2008-02-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Demeclocycline Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 29O079NTYT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905341 Internal RxNorm lookup 905347 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 53746-555-48 Demeclocycline Hydrochloride 48 in 1 BOTTLE TABLET 48 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-555 DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 3 Current NDC, Legacy NDC, 1 package rows 20230217_539add06-e0a0-401a-b4f6-20776084aa9c.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53746-555-48 53746055548 48 TABLET in 1 BOTTLE (53746-555-48) 48 tablet 2022-05-25 0000-00-00 No No Current