Home NDC 72789-477 Carisoprodol Tablets, USP, 350 mg
Product NDC 72789-477
11-digit product format 727890477
Labeler code 72789
Product ID 72789-477_41d80caa-d146-cdc1-e063-6294a90a8dc3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carisoprodol
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA211789
Marketing category ANDA
Marketing start 2025-05-11
Substance CARISOPRODOL
Active strength 350 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 42 .
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 A211789-001 CARISOPRODOL CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211789-001 AA
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 2026-08-18 06:07:40 2026-07 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211789-001 CARISOPRODOL 350MG TABLET / ORAL 2021-10-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211789-001 CARISOPRODOL 350MG TABLET / ORAL 2021-10-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211789-001 CARISOPRODOL 350MG TABLET / ORAL 2021-10-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211789-001 CARISOPRODOL 350MG TABLET / ORAL 2021-10-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211789-001 CARISOPRODOL 350MG TABLET / ORAL 2021-10-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211789-001 CARISOPRODOL 350MG TABLET / ORAL AA 2021-10-20 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Carisoprodol Tablets, USP, 350 mg
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARISOPRODOL 350 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 197446 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 72789-477-01 Carisoprodol Tablets, USP, 350 mg 100 in 1 BOTTLE, PLASTIC TABLET 100 6 72789-477-30 Carisoprodol Tablets, USP, 350 mg 30 in 1 BOTTLE, PLASTIC TABLET 30 6 72789-477-90 Carisoprodol Tablets, USP, 350 mg 90 in 1 BOTTLE, PLASTIC TABLET 90 6 72789-477-95 Carisoprodol Tablets, USP, 350 mg 1000 in 1 BOTTLE, PLASTIC TABLET 1000 6 72789-477-98 Carisoprodol Tablets, USP, 350 mg 120 in 1 BOTTLE, PLASTIC TABLET 120 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-477 CARISOPRODOL TABLETS, USP, 350 MG (CARISOPRODOL) TABLET [PD-RX PHARMACEUTICALS, INC.] 2 Current NDC, 5 package rows 20250205_1f08f4af-37c2-49b5-a4e3-284414f866fa.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carisoprodol Tablets, USP, 350 mg CARISOPRODOL Bryant Ranch Prepack 35a8e0a4-93a3-44e3-903f-4661ee1cffe8 2025-12-03 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211789 application number: ANDA211789 Carisoprodol Tablets, USP, 350 mg CARISOPRODOL Bryant Ranch Prepack 409b04af-b9fd-4ba5-afa0-3e43466f8d2d 2025-12-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211789 application number: ANDA211789 Carisoprodol Tablets, USP, 350 mg CARISOPRODOL PD-Rx Pharmaceuticals, Inc. 1f08f4af-37c2-49b5-a4e3-284414f866fa 2025-10-23 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211789 application number: ANDA211789 ndc (product): 72789-477 Carisoprodol Tablets, USP, 350 mg CARISOPRODOL Granulation Technology, Inc. 2abd11e4-8ce4-4aeb-87c4-3af94c197714 2025-06-11 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211789 application number: ANDA211789
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72789-477-01 72789047701 100 TABLET in 1 BOTTLE, PLASTIC (72789-477-01) 100 tablet 2025-05-11 No No Current 72789-477-30 72789047730 30 TABLET in 1 BOTTLE, PLASTIC (72789-477-30) 30 tablet 2025-10-23 No No Current 72789-477-90 72789047790 90 TABLET in 1 BOTTLE, PLASTIC (72789-477-90) 90 tablet 2025-08-06 No No Current 72789-477-95 72789047795 1000 TABLET in 1 BOTTLE, PLASTIC (72789-477-95) 1000 tablet 2025-05-11 No No Current 72789-477-98 72789047798 120 TABLET in 1 BOTTLE, PLASTIC (72789-477-98) 120 tablet 2025-08-12 No No Current