CARISOPRODOL

Product NDC: 50228-109
11-digit product format: 502280109
Labeler code: 50228
Product ID: 50228-109_60f38a99-69ef-4d7e-80b0-555575993116
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CARISOPRODOL
Dosage form: TABLET
Route: ORAL
Labeler: ScieGen Pharmaceuticals, Inc.
Application: ANDA203374
Marketing category: ANDA
Marketing start: 2014-01-27
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: 2027-12-31
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
A203374-001	CARISOPRODOL	CARISOPRODOL	350MG	TABLET / ORAL	AA		2014-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A203374-001	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.

Product history page 1 of 2 · 42 observed 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
2026-08-18 06:07:40	2026-07	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203374-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203374-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203374-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203374-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203374-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203374-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203374-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203374-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203374-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203374-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203374-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203374-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203374-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203374-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203374-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203374-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203374-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203374-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203374-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203374-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203374-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203374-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203374-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203374-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203374-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203374-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203374-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203374-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203374-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203374-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203374-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203374-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203374-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203374-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203374-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203374-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203374-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203374-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203374-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203374-001	AA	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: CARISOPRODOL
Listing expiration: 2027-12-31

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
069ea892-21a6-4703-8dd3-bf19c4406479	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
50228-109-01	CARISOPRODOL	100 in 1 BOTTLE	TABLET	100	6
50228-109-05	CARISOPRODOL	500 in 1 BOTTLE	TABLET	500	6
50228-109-10	CARISOPRODOL	1000 in 1 BOTTLE	TABLET	1000	6
50228-109-30	CARISOPRODOL	30 in 1 BOTTLE	TABLET	30	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50228-109-01	EA - Each	50228-109	9e4aebe7-8340-43fa-b8bd-0ffd48d0676d	1	2019-03-12
50228-109-05	EA - Each	50228-109	3f628e21-9992-4b09-9f2b-0d54ed4a5952	1	2019-03-12
50228-109-10	EA - Each	50228-109	cc3dcff3-a435-4603-a09c-645b5e971d44	1	2019-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARISOPRODOL	ACTIVE INGREDIENT	21925K482H	CARISOPRODOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
CARISOPRODOL	ACTIVE INGREDIENT	21925K482H	CARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]	2
CARISOPRODOL	ACTIVE MOIETY	21925K482H	CARISOPRODOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
CARISOPRODOL	ACTIVE MOIETY	21925K482H	CARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARISOPRODOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CARISOPRODOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARISOPRODOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARISOPRODOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CARISOPRODOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARISOPRODOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARISOPRODOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50228-109	CARISOPRODOL TABLET [SCIEGEN PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 4 package rows	20230108_069ea892-21a6-4703-8dd3-bf19c4406479.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARISOPRODOL	CARISOPRODOL	Northwind Health Company, LLC	26e466be-8066-e562-e063-6394a90a9f81	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374
CARISOPRODOL	CARISOPRODOL	St. Mary's Medical Park Pharmacy	94f74800-1f0d-7814-e053-2a95a90a4f63	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	269644bf-d32c-48a3-b3eb-1221150ebd22	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	59f6f0e3-fdbd-4788-9944-37edde4b9a3c	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	a3f1343f-1337-4b99-b1ae-4189324ec2e9	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	93f909ea-2d2e-4a10-be50-7f33f3e904d4	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374
CARISOPRODOL	CARISOPRODOL	ScieGen Pharmaceuticals, Inc.	069ea892-21a6-4703-8dd3-bf19c4406479	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374 ndc (product): 50228-109
Carisoprodol	CARISOPRODOL	Direct_Rx	8e9bb49a-8cc3-4390-e053-2a95a90a4e0e	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374
Carisoprodol	CARISOPRODOL	Advanced Rx Pharmacy of Tennessee, LLC	f835e66e-f3f3-c3cf-e053-6294a90addf2	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	fdd6318f-399f-499c-acdc-5318aa080f36	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374
CARISOPRODOL	CARISOPRODOL	NuCare Pharmaceuticals,Inc.	93cbe188-5443-b392-e053-2995a90a9ac7	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374
CARISOPRODOL	CARISOPRODOL	Asclemed USA, Inc.	4221d7d1-d7d6-46c4-be41-8c8e99129324	2023-11-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374
CARISOPRODOL	CARISOPRODOL	Proficient Rx LP	2178e805-8189-459f-a447-21bf1547744a	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374
CARISOPRODOL	CARISOPRODOL	Proficient Rx LP	efd7a0b4-5ec5-4929-a4cb-7d207171eed6	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374
CARISOPRODOL	CARISOPRODOL	Vensun Pharmaceuticals, Inc.	7c6015ad-2158-400d-8c22-585ab277ea49	2018-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374

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	a3f1343f-1337-4b99-b1ae-4189324ec2e9	104
197446	carisoprodol 350 MG Oral Tablet	PSN	93f909ea-2d2e-4a10-be50-7f33f3e904d4	104
197446	carisoprodol 350 MG Oral Tablet	PSN	59f6f0e3-fdbd-4788-9944-37edde4b9a3c	104
197446	carisoprodol 350 MG Oral Tablet	SCD	a3f1343f-1337-4b99-b1ae-4189324ec2e9	104
197446	carisoprodol 350 MG Oral Tablet	SCD	93f909ea-2d2e-4a10-be50-7f33f3e904d4	104
197446	carisoprodol 350 MG Oral Tablet	SCD	59f6f0e3-fdbd-4788-9944-37edde4b9a3c	104
197446	carisoprodol 350 MG Oral Tablet	PSN	269644bf-d32c-48a3-b3eb-1221150ebd22	100
197446	carisoprodol 350 MG Oral Tablet	SCD	269644bf-d32c-48a3-b3eb-1221150ebd22	100
197446	carisoprodol 350 MG Oral Tablet	PSN	069ea892-21a6-4703-8dd3-bf19c4406479	6
197446	carisoprodol 350 MG Oral Tablet	PSN	fdd6318f-399f-499c-acdc-5318aa080f36	6
197446	carisoprodol 350 MG Oral Tablet	SCD	fdd6318f-399f-499c-acdc-5318aa080f36	6
197446	carisoprodol 350 MG Oral Tablet	SCD	069ea892-21a6-4703-8dd3-bf19c4406479	6
197446	carisoprodol 350 MG Oral Tablet	PSN	8e9bb49a-8cc3-4390-e053-2a95a90a4e0e	5
197446	carisoprodol 350 MG Oral Tablet	SCD	8e9bb49a-8cc3-4390-e053-2a95a90a4e0e	5
197446	carisoprodol 350 MG Oral Tablet	PSN	2178e805-8189-459f-a447-21bf1547744a	3
197446	carisoprodol 350 MG Oral Tablet	PSN	94f74800-1f0d-7814-e053-2a95a90a4f63	3
197446	carisoprodol 350 MG Oral Tablet	PSN	67f54a7d-e41d-420e-90f4-9c46d19de41c	3
197446	carisoprodol 350 MG Oral Tablet	PSN	93cbe188-5443-b392-e053-2995a90a9ac7	3
197446	carisoprodol 350 MG Oral Tablet	SCD	94f74800-1f0d-7814-e053-2a95a90a4f63	3
197446	carisoprodol 350 MG Oral Tablet	SCD	2178e805-8189-459f-a447-21bf1547744a	3
197446	carisoprodol 350 MG Oral Tablet	SCD	93cbe188-5443-b392-e053-2995a90a9ac7	3
197446	carisoprodol 350 MG Oral Tablet	SCD	67f54a7d-e41d-420e-90f4-9c46d19de41c	3
197446	carisoprodol 350 MG Oral Tablet	PSN	26e466be-8066-e562-e063-6394a90a9f81	2
197446	carisoprodol 350 MG Oral Tablet	PSN	f835e66e-f3f3-c3cf-e053-6294a90addf2	2
197446	carisoprodol 350 MG Oral Tablet	SCD	26e466be-8066-e562-e063-6394a90a9f81	2
197446	carisoprodol 350 MG Oral Tablet	SCD	f835e66e-f3f3-c3cf-e053-6294a90addf2	2
197446	carisoprodol 350 MG Oral Tablet	PSN	8bdb858f-2c36-780f-e053-2995a90a3a22	1
197446	carisoprodol 350 MG Oral Tablet	PSN	4221d7d1-d7d6-46c4-be41-8c8e99129324	1
197446	carisoprodol 350 MG Oral Tablet	PSN	8a845530-8bec-f872-e053-2a95a90ad530	1
197446	carisoprodol 350 MG Oral Tablet	PSN	9af17486-02ed-a54b-e053-2a95a90ad8b3	1
197446	carisoprodol 350 MG Oral Tablet	PSN	aa6aa4dd-70b1-d942-e053-2995a90a9cde	1
197446	carisoprodol 350 MG Oral Tablet	SCD	4221d7d1-d7d6-46c4-be41-8c8e99129324	1
197446	carisoprodol 350 MG Oral Tablet	SCD	8bdb858f-2c36-780f-e053-2995a90a3a22	1
197446	carisoprodol 350 MG Oral Tablet	SCD	9af17486-02ed-a54b-e053-2a95a90ad8b3	1
197446	carisoprodol 350 MG Oral Tablet	SCD	aa6aa4dd-70b1-d942-e053-2995a90a9cde	1
197446	carisoprodol 350 MG Oral Tablet	SCD	8a845530-8bec-f872-e053-2a95a90ad530	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50228-109-01	50228010901	100 TABLET in 1 BOTTLE (50228-109-01)	100 tablet	2014-01-27	0000-00-00	No	No	Current
50228-109-05	50228010905	500 TABLET in 1 BOTTLE (50228-109-05)	500 tablet	2014-01-27	0000-00-00	No	No	Current
50228-109-10	50228010910	1000 TABLET in 1 BOTTLE (50228-109-10)	1000 tablet	2014-01-27	0000-00-00	No	No	Current
50228-109-30	50228010930	30 TABLET in 1 BOTTLE (50228-109-30)	30 tablet	2014-01-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CARISOPRODOL	Northwind Health Company, LLC	2026-06-22	HUMAN PRESCRIPTION DRUG LABEL	3
CARISOPRODOL	St. Mary's Medical Park Pharmacy	2026-06-17	HUMAN PRESCRIPTION DRUG LABEL	4
CARISOPRODOL	Bryant Ranch Prepack	2026-06-16	HUMAN PRESCRIPTION DRUG LABEL	101
CARISOPRODOL	Bryant Ranch Prepack	2026-05-28	HUMAN PRESCRIPTION DRUG LABEL	104
CARISOPRODOL	Bryant Ranch Prepack	2026-05-28	HUMAN PRESCRIPTION DRUG LABEL	104
CARISOPRODOL	Bryant Ranch Prepack	2026-05-28	HUMAN PRESCRIPTION DRUG LABEL	104
CARISOPRODOL	ScieGen Pharmaceuticals, Inc.	2026-02-27	HUMAN PRESCRIPTION DRUG LABEL	6
Carisoprodol	Direct_Rx	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	5
Carisoprodol Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2
CARISOPRODOL	Bryant Ranch Prepack	2024-08-29	HUMAN PRESCRIPTION DRUG LABEL	6
CARISOPRODOL	NuCare Pharmaceuticals,Inc.	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	3
CARISOPRODOL	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-11-29	HUMAN PRESCRIPTION DRUG LABEL	1
CARISOPRODOL	Golden State Medical Supply, Inc.	2023-01-16	HUMAN PRESCRIPTION DRUG LABEL	7
CARISOPRODOL	Proficient Rx LP	2022-05-01	HUMAN PRESCRIPTION DRUG LABEL	3
CARISOPRODOL	Bryant Ranch Prepack	2021-12-23	HUMAN PRESCRIPTION DRUG LABEL	2
CARISOPRODOL	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-07-14	HUMAN PRESCRIPTION DRUG LABEL	1
CARISOPRODOL	medsource pharmaceuticals	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	1
CARISOPRODOL	Unit Dose Services	2019-09-12	HUMAN PRESCRIPTION DRUG LABEL	3
CARISOPRODOL	Quality Care Products, LLC	2019-06-28	HUMAN PRESCRIPTION DRUG LABEL	1
Carisoprodol	Direct_Rx	2019-06-21	HUMAN PRESCRIPTION DRUG LABEL	1
CARISOPRODOL	Direct_Rx	2019-06-04	HUMAN PRESCRIPTION DRUG LABEL	1