Home NDC 25021-651 Orphenadrine Citrate
Product NDC 25021-651
11-digit product format 250210651
Labeler code 25021
Product ID 25021-651_393d82d5-94f5-43fd-b5c8-d0554795233f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name orphenadrine citrate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA090585
Marketing category ANDA
Marketing start 2011-10-01
Substance ORPHENADRINE CITRATE
Active strength 30 mg/mL
Pharmacologic classes Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [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 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 A090585-001 ORPHENADRINE CITRATE ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090585-001 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 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 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090585-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2011-08-30 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 Orphenadrine Citrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ORPHENADRINE CITRATE 30 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X0A40N8I4S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 994541 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 25021-651-02 Orphenadrine Citrate 2 mL in 1 VIAL INJECTION, SOLUTION 2 5 25021-651-02 Orphenadrine Citrate 10 in 1 CARTON INJECTION, SOLUTION 10 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-651 ORPHENADRINE CITRATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 2 package rows 20231227_c8d8596a-b81f-4b83-a2f3-a55922ca4a82.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 Sample Exclude flag Status 25021-651-02 25021065102 10 VIAL in 1 CARTON (25021-651-02) / 2 mL in 1 VIAL 10 vial 2011-10-01 No No Current