Home NDC 0641-6182 Orphenadrine citrate
Product NDC 0641-6182
11-digit product format 006416182
Labeler code 0641
Product ID 0641-6182_dde13b7f-78fb-4b9a-bc16-a41bf45042be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Orphenadrine citrate
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA040463
Marketing category ANDA
Marketing start 2003-04-28
Substance ORPHENADRINE CITRATE
Active strength 60 mg/2mL
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 A040463-001 ORPHENADRINE CITRATE ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040463-001 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 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040463-001 ORPHENADRINE CITRATE 30MG/ML INJECTABLE / INJECTION AP 2003-03-04 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 60 mg/2mL
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 0641-6182-01 Orphenadrine citrate 2 mL in 1 VIAL INJECTION 2 5 0641-6182-10 Orphenadrine citrate 10 in 1 BOX INJECTION 10 5 0641-6182-25 Orphenadrine citrate 25 in 1 BOX INJECTION 25 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6182 ORPHENADRINE CITRATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 5 Current NDC, Legacy NDC, 3 package rows 20240809_ed406e8a-ec00-4711-ae2b-3c5af4f15438.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 0641-6182-01 00641618201 2 mL in 1 VIAL 2 ml Historical 0641-6182-10 00641618210 10 VIAL in 1 BOX (0641-6182-10) > 2 mL in 1 VIAL (0641-6182-01) 10 vial 2003-04-28 0000-00-00 No No Current 0641-6182-25 00641618225 25 BOX in 1 BOX (0641-6182-25) / 10 VIAL in 1 BOX (0641-6182-10) / 2 mL in 1 VIAL (0641-6182-01) 25 box 2003-04-28 No No Current