Home NDC 24658-710 Demeclocycline Hydrochloride
Product NDC 24658-710
11-digit product format 246580710
Labeler code 24658
Product ID 24658-710_aa40e353-18db-4553-8f8d-a434eac8ed1f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Demeclocycline Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PuraCap Laboratories LLC
Application ANDA065447
Marketing category ANDA
Marketing start 2017-10-07
Substance DEMECLOCYCLINE HYDROCHLORIDE
Active strength 150 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 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18
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 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEMECLOCYCLINE HYDROCHLORIDE 150 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 24658-710-01 Demeclocycline Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24658-710 DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [PURACAP LABORATORIES LLC] 5 Current NDC, Legacy NDC, 1 package rows 20241222_88e03cb0-25f5-41a5-b77f-58ab8f3be181.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 24658-710-01 24658071001 100 TABLET, FILM COATED in 1 BOTTLE (24658-710-01) 2017-10-07 0000-00-00 No No Current