Carisoprodol Tablets, USP, 350 mg

Product NDC: 72789-477
Requested package NDC: 72789-477-01
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 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
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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211789-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2021-10-20	`84e616aacf4f…`
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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211789-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211789-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211789-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211789-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211789-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211789-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211789-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211789-001	AA	1	`03ed91905a0d…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211789-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211789-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211789-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211789-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211789-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211789-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211789-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211789-001	AA	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211789-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211789-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211789-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211789-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211789-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211789-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211789-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211789-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211789-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211789-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211789-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211789-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211789-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211789-001	AA	1	`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: 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1f08f4af-37c2-49b5-a4e3-284414f866fa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
780d53a1-1665-e26e-d112-85333c0c8a2e	Product name	5	20220516
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-477-01	EA - Each	72789-477	6ba71bc2-c12c-4090-bdd9-6feb3831af3a	1	2025-03-04
72789-477-30	EA - Each	72789-477	62fa752f-8176-4551-a8d6-9da9fcf82aff	1	2025-12-16
72789-477-90	EA - Each	72789-477	c4e506c8-ad07-4054-a8a2-f3b25cf01d63	1	2025-09-12
72789-477-95	EA - Each	72789-477	b3aed56f-47ca-4d88-8910-c5801e7d1bf3	1	2025-03-04
72789-477-98	EA - Each	72789-477	bd971ed3-6e2e-4c0e-862d-dea2370afb1f	1	2025-09-12

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 (package): 72789-477-01 ndc (product): 72789-477 ndc11 (package): 72789047701
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
21925K482H	CARISOPRODOL	78-44-4	CARISOPRODOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197446	carisoprodol 350 MG Oral Tablet	PSN	1f08f4af-37c2-49b5-a4e3-284414f866fa	6
197446	carisoprodol 350 MG Oral Tablet	SCD	1f08f4af-37c2-49b5-a4e3-284414f866fa	6

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carisoprodol Tablets, USP, 350 mg	PD-Rx Pharmaceuticals, Inc.	2025-10-23	HUMAN PRESCRIPTION DRUG LABEL	6