Home NDC 69528-701-05 ATMEKSI
Product NDC 69528-701
Requested package NDC 69528-701-05
11-digit product format 695280701
Labeler code 69528
Product ID 69528-701_4ce9560d-185c-1e28-e063-6294a90af77f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methocarbamol
Dosage form SUSPENSION
Route ORAL
Labeler Rosemont Pharmaceuticals LLC
Application NDA219843
Marketing category NDA
Marketing start 2025-12-22
Substance METHOCARBAMOL
Active strength 750 mg/5mL
Pharmacologic classes Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
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 N219843-001 ATMEKSI METHOCARBAMOL 750MG/5ML SUSPENSION / ORAL RLD, RS 2025-07-30
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219843-001 12390439 2044-10-09 U-4253 Drug product 2025-08-19
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.
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 N219843-001 ATMEKSI 750MG/5ML SUSPENSION / ORAL RLD, RS 2025-07-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219843-001 ATMEKSI 750MG/5ML SUSPENSION / ORAL RLD, RS 2025-07-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219843-001 ATMEKSI 750MG/5ML SUSPENSION / ORAL RLD, RS 2025-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219843-001 ATMEKSI 750MG/5ML SUSPENSION / ORAL RLD, RS 2025-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219843-001 ATMEKSI 750MG/5ML SUSPENSION / ORAL RLD, RS 2025-07-30 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219843-001 ATMEKSI 750MG/5ML SUSPENSION / ORAL RLD, RS 2025-07-30 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N219843-001 12390439 2044-10-09 U-4253 Drug product 2025-08-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219843-001 12390439 2044-10-09 U-4253 Drug product 2025-08-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219843-001 12390439 2044-10-09 U-4253 Drug product 2025-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219843-001 12390439 2044-10-09 U-4253 Drug product 2025-08-19 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219843-001 12390439 2044-10-09 U-4253 Drug product 2025-08-19 a50c72e98297…
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 ATMEKSI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHOCARBAMOL 750 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 125OD7737X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2729335 Internal RxNorm lookup 2729341 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 69528-701-05 ATMEKSI 150 mL in 1 BOTTLE SUSPENSION 150 3
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 69528-701-05 69528070105 150 mL in 1 BOTTLE (69528-701-05) 150 ml 2026-01-15 No No Current