Home NDC 67457-218 Duraclon
Product NDC 67457-218
11-digit product format 674570218
Labeler code 67457
Product ID 67457-218_671a0224-c38b-4f2e-a132-fa38aa1a0797
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clonidine hydrochloride
Dosage form INJECTION, SOLUTION
Route EPIDURAL
Labeler Mylan Institutional LLC
Application NDA020615
Marketing category NDA
Marketing start 1997-01-26
Substance CLONIDINE HYDROCHLORIDE
Active strength .1 mg/mL
Pharmacologic classes Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
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 N020615-001 DURACLON CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 N020615-002 DURACLON CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1999-04-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020615-001 AP
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 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1999-04-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1999-04-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1999-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1999-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1999-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1999-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1999-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1999-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1999-04-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1999-04-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1999-04-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1999-04-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1999-04-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1999-04-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1999-04-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1999-04-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION RLD 1999-04-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION RLD 1999-04-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION RLD 1999-04-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020615-001 DURACLON 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP RLD 1996-10-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020615-002 DURACLON 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-04-27 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 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 Duraclon
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLONIDINE HYDROCHLORIDE .1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W76I6XXF06 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 884221 Internal RxNorm lookup 884223 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 67457-218-10 Duraclon 1 in 1 CARTON INJECTION, SOLUTION 1 10 67457-218-10 Duraclon 10 mL in 1 VIAL INJECTION, SOLUTION 10 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-218 DURACLON (CLONIDINE HYDROCHLORIDE) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 10 Current NDC, Legacy NDC, 2 package rows 20210520_8c126bb8-732a-4949-8754-2f50b5543638.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Duraclon CLONIDINE HYDROCHLORIDE Mylan Institutional LLC 8c126bb8-732a-4949-8754-2f50b5543638 2021-03-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020615 application number: NDA020615 ndc (product): 67457-218
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 67457-218-10 67457021810 1 VIAL in 1 CARTON (67457-218-10) / 10 mL in 1 VIAL 1 vial 1997-01-26 0000-00-00 No No Current