Home NDC 62135-877 doxycycline
Product NDC 62135-877
11-digit product format 621350877
Labeler code 62135
Product ID 62135-877_40077986-5ebb-f8f0-e063-6394a90ad09f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doxycycline
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Chartwell RX LLC
Application ANDA065454
Marketing category ANDA
Marketing start 2008-07-16
Substance DOXYCYCLINE
Active strength 25 mg/5mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065454-001 DOXYCYCLINE DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065454-001 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 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYCYCLINE 25 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 19XTS3T51U Internal UNII lookup N12000U13O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1649405 Internal RxNorm lookup 1649988 Internal RxNorm lookup 1650030 Internal RxNorm lookup 1650143 Internal RxNorm lookup 1652674 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 62135-877-46 doxycycline 60 mL in 1 BOTTLE, GLASS POWDER, FOR SUSPENSION 60 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Doxycycline Hyclate ACTIVE INGREDIENT 19XTS3T51U DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] 3 Doxycycline Anhydrous ACTIVE MOIETY 334895S862 DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] 3 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] 3 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] 3 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] 3 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] 3 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] 3 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] 3 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] 3 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] 3 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-877 DOXYCYCLINE HYCLATE TABLET, FILM COATED DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE POWDER, FOR SUSPENSION [CHARTWELL RX LLC] 15 Current NDC, 1 package rows 20240402_3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35.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 Sample Exclude flag Status 62135-877-46 62135087746 60 mL in 1 BOTTLE, GLASS (62135-877-46) 60 ml 2024-03-27 No No Current