Orphenadrine Citrate

Product NDC: 63187-632
11-digit product format: 631870632
Labeler code: 63187
Product ID: 63187-632_77186922-128f-4ed4-8caa-b45fce773345
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Orphenadrine Citrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA040327
Marketing category: ANDA
Marketing start: 2000-02-15
Substance: ORPHENADRINE CITRATE
Active strength: 100 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
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 1.

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
A040327-001	ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040327-001	AB

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040327-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-02-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040327-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040327-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040327-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040327-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040327-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040327-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040327-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040327-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040327-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040327-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040327-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040327-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040327-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040327-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040327-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040327-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040327-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040327-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040327-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040327-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040327-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040327-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040327-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040327-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040327-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040327-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040327-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040327-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040327-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040327-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040327-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040327-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040327-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040327-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040327-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040327-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040327-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040327-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040327-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040327-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Orphenadrine Citrate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ORPHENADRINE CITRATE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X0A40N8I4S	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
994521	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
37e6a157-5d0d-4887-9a26-ed5521fb08e6	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63187-632-30	Orphenadrine Citrate	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	2
63187-632-60	Orphenadrine Citrate	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	2
63187-632-90	Orphenadrine Citrate	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-632-60	EA - Each	63187-632	718ebdd6-ad7b-430f-bc1e-c11b74fb13fd	1	2016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-632	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]	2	Current NDC, Legacy NDC, 3 package rows	20191128_37e6a157-5d0d-4887-9a26-ed5521fb08e6.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Orphenadrine Citrate	ORPHENADRINE CITRATE	RedPharm Drug	1cff761d-e594-a9e6-e063-6394a90a1fd5	2024-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040327 application number: ANDA040327
Orphenadrine Citrate	ORPHENADRINE CITRATE	Sandoz Inc	239018ff-cec6-46de-ae9d-26c9ec034a32	2024-03-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040327 application number: ANDA040327
Orphenadrine Citrate	ORPHENADRINE CITRATE	Proficient Rx LP	37e6a157-5d0d-4887-9a26-ed5521fb08e6	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040327 application number: ANDA040327 ndc (product): 63187-632

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X0A40N8I4S	ORPHENADRINE CITRATE	4682-36-4	ORPHENADRINE CITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	37e6a157-5d0d-4887-9a26-ed5521fb08e6	2
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	37e6a157-5d0d-4887-9a26-ed5521fb08e6	2
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	37e6a157-5d0d-4887-9a26-ed5521fb08e6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-632-30	63187063230	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-632-30)	2016-01-01	0000-00-00	No	No	Current
63187-632-60	63187063260	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-632-60)	2016-01-01	0000-00-00	No	No	Current
63187-632-90	63187063290	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-632-90)	2016-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Orphenadrine Citrate Extended-Release Tablets	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	2