Home NDC 42806-144-01 Demeclocycline Hydrochloride
Product NDC 42806-144
Requested package NDC 42806-144-01
11-digit product format 428060144
Labeler code 42806
Product ID 42806-144_b84008e7-52db-4b3e-a12e-cb939852ff0f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Demeclocycline Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA065447
Marketing category ANDA
Marketing start 2015-02-02
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 43 .
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 · 86 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 2026-09-14 22:38:34 2026-08 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065447-001 DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2015-08-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065447-002 DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET / ORAL AB 2015-08-18 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 Demeclocycline Hydrochloride
Listing expiration 2026-12-31 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 42806-144-01 Demeclocycline Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 8 42806-144-30 Demeclocycline Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 8 42806-144-48 Demeclocycline Hydrochloride 48 in 1 BOTTLE TABLET, FILM COATED 48 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEMECLOCYCLINE HYDROCHLORIDE ACTIVE INGREDIENT 29O079NTYT DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 DEMECLOCYCLINE ACTIVE MOIETY 5R5W9ICI6O DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 HYDROXYPROPYL CELLULOSE (TYPE L) INACTIVE INGREDIENT UKE75GEA7F DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 HYPROMELLOSE 2910 (10000 MPA.S) INACTIVE INGREDIENT 0HO1H52958 DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-144 DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 8 Current NDC, Legacy NDC, 3 package rows 20231221_645af8f4-0843-4afb-9ddc-f587f38adb68.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 42806-144-01 42806014401 100 TABLET, FILM COATED in 1 BOTTLE (42806-144-01) 2015-02-02 0000-00-00 No No Current