Home NDC 51525-5901 Carisoprodol
Product NDC 51525-5901
11-digit product format 515255901
Labeler code 51525
Product ID 51525-5901_8c92753a-4b60-4ecf-b411-d66665ae493e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carisoprodol
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA011792
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2016-10-01
Substance CARISOPRODOL
Active strength 250 mg/1
Pharmacologic classes Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
DEA schedule CIV
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N011792-001 SOMA CARISOPRODOL 350MG TABLET / ORAL AA RLD, Approved before 1982 N011792-003 SOMA CARISOPRODOL 250MG CAPSULE / ORAL RLD, Approved before 1982 N011792-004 SOMA CARISOPRODOL 250MG TABLET / ORAL AB RLD, RS 2007-09-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 4 · 129 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 N011792-001 SOMA 350MG TABLET / ORAL AA RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N011792-003 SOMA 250MG CAPSULE / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N011792-004 SOMA 250MG TABLET / ORAL AB RLD, RS 2007-09-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N011792-001 SOMA 350MG TABLET / ORAL AA RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N011792-003 SOMA 250MG CAPSULE / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N011792-004 SOMA 250MG TABLET / ORAL AB RLD, RS 2007-09-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N011792-001 SOMA 350MG TABLET / ORAL AA RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N011792-003 SOMA 250MG CAPSULE / ORAL RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N011792-004 SOMA 250MG TABLET / ORAL AB RLD, RS 2007-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N011792-001 SOMA 350MG TABLET / ORAL AA RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N011792-003 SOMA 250MG CAPSULE / ORAL RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N011792-004 SOMA 250MG TABLET / ORAL AB RLD, RS 2007-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N011792-001 SOMA 350MG TABLET / ORAL AA RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N011792-003 SOMA 250MG CAPSULE / ORAL RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N011792-004 SOMA 250MG TABLET / ORAL AB RLD, RS 2007-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N011792-001 SOMA 350MG TABLET / ORAL AA RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N011792-003 SOMA 250MG CAPSULE / ORAL RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N011792-004 SOMA 250MG TABLET / ORAL AB RLD, RS 2007-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N011792-001 SOMA 350MG TABLET / ORAL AA RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N011792-003 SOMA 250MG CAPSULE / ORAL RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N011792-004 SOMA 250MG TABLET / ORAL AB RLD, RS 2007-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N011792-001 SOMA 350MG TABLET / ORAL AA RLD, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N011792-003 SOMA 250MG CAPSULE / ORAL RLD, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N011792-004 SOMA 250MG TABLET / ORAL AB RLD, RS 2007-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N011792-001 SOMA 350MG TABLET / ORAL AA RLD, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N011792-003 SOMA 250MG CAPSULE / ORAL RLD, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N011792-004 SOMA 250MG TABLET / ORAL AB RLD, RS 2007-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N011792-001 SOMA 350MG TABLET / ORAL AA RLD, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N011792-003 SOMA 250MG CAPSULE / ORAL RLD, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N011792-004 SOMA 250MG TABLET / ORAL AB RLD, RS 2007-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N011792-001 SOMA 350MG TABLET / ORAL AA RLD, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N011792-003 SOMA 250MG CAPSULE / ORAL RLD, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N011792-004 SOMA 250MG TABLET / ORAL AB RLD, RS 2007-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N011792-001 SOMA 350MG TABLET / ORAL AA RLD, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N011792-003 SOMA 250MG CAPSULE / ORAL RLD, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N011792-004 SOMA 250MG TABLET / ORAL AB RLD, RS 2007-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N011792-001 SOMA 350MG TABLET / ORAL AA RLD, Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N011792-003 SOMA 250MG CAPSULE / ORAL RLD, Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N011792-004 SOMA 250MG TABLET / ORAL AB RLD, RS 2007-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N011792-001 SOMA 350MG TABLET / ORAL AA RLD, Approved before 1982 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 Carisoprodol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARISOPRODOL 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 21925K482H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 730794 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 51525-5901-1 Carisoprodol 100 in 1 BOTTLE TABLET 100 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51525-5901 CARISOPRODOL TABLET [WALLACE PHARMACEUTICALS INC.] 8 Current NDC, Legacy NDC, 1 package rows 20250311_7c9184c0-7a2e-11df-8c8d-0002a5d5c51b.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 · 2 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 51525-5901-1 51525590101 100 TABLET in 1 BOTTLE (51525-5901-1) 100 tablet 2016-10-01 0000-00-00 No No Current