Home NDC 0591-3222 Orphenadrine Citrate
Product NDC 0591-3222
11-digit product format 005913222
Labeler code 0591
Product ID 0591-3222_76bd2057-e1ac-4529-9663-f6139218eeab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Orphenadrine Citrate
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Actavis Pharma, Inc.
Application ANDA084779
Marketing category ANDA
Marketing start 2010-07-08
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 A084779-001 ORPHENADRINE CITRATE ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A084779-001 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 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A084779-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 1982-03-15 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 0591-3222-02 Orphenadrine Citrate 2 mL in 1 AMPULE INJECTION 2 6 0591-3222-47 Orphenadrine Citrate 10 in 1 CARTON INJECTION 10 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-3222 ORPHENADRINE CITRATE INJECTION [ACTAVIS PHARMA, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20181201_aec8ad3a-f717-4e74-b7b9-19debdaad79a.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 0591-3222-02 00591322202 2 mL in 1 AMPULE 2 ml Historical 0591-3222-47 00591322247 10 AMPULE in 1 CARTON (0591-3222-47) / 2 mL in 1 AMPULE (0591-3222-02) 10 ampule 2010-07-08 0000-00-00 No No Current