Home NDC 68180-657 DOXYCYCLINE
Product NDC 68180-657
11-digit product format 681800657
Labeler code 68180
Product ID 68180-657_6e5c9f41-4304-4121-845f-b894a4fd5d95
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOXYCYCLINE
Dosage form FOR SUSPENSION
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA201678
Marketing category ANDA
Marketing start 2013-06-11
Substance DOXYCYCLINE
Active strength 25 mg/5mL
Pharmacologic classes Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201678-001 DOXYCYCLINE DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2013-03-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201678-001 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 · 43 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 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2013-03-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2013-03-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2013-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2013-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2013-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2013-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2013-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2013-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2013-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2013-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2013-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2013-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2013-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2013-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201678-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-03-18 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 DOXYCYCLINE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYCYCLINE 25 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N12000U13O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1650030 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 68180-657-01 DOXYCYCLINE 60 mL in 1 BOTTLE FOR SUSPENSION 60 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXYCYCLINE ACTIVE INGREDIENT N12000U13O DOXYCYCLINE FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 8 DOXYCYCLINE ANHYDROUS ACTIVE MOIETY 334895S862 DOXYCYCLINE FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 8 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 DOXYCYCLINE FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DOXYCYCLINE FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 8 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH DOXYCYCLINE FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 8 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DOXYCYCLINE FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 8 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T DOXYCYCLINE FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 8 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH DOXYCYCLINE FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 8 RASPBERRY INACTIVE INGREDIENT 4N14V5R27W DOXYCYCLINE FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 8 SUCROSE INACTIVE INGREDIENT C151H8M554 DOXYCYCLINE FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-657 DOXYCYCLINE FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 17 Current NDC, Legacy NDC, 1 package rows 20250124_e0e80435-1b6a-4361-8c8a-e432f8f23a1b.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 · 1 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 68180-657-01 68180065701 60 mL in 1 BOTTLE (68180-657-01) 60 ml 2013-06-11 0000-00-00 No No Current