Orphenadrine Citrate

Product NDC: 71335-0117
Requested package NDC: 71335-0117-2
11-digit product format: 713350117
Labeler code: 71335
Product ID: 71335-0117_30996f91-5b58-431b-94f5-842db03be6f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Orphenadrine Citrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA040327
Marketing category: ANDA
Marketing start: 2000-02-15
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71335-0117	71335-0117-2	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0117-0	EA - Each	71335-0117	b485ff27-504b-45e8-9750-d433484c3c41	1	2018-03-08
71335-0117-1	EA - Each	71335-0117	c5aaad32-68f4-4634-8335-26beb88c90cd	1	2018-03-08
71335-0117-2	EA - Each	71335-0117	d735fdd6-55b7-460a-b276-b23b3e57f4da	1	2018-03-08
71335-0117-3	EA - Each	71335-0117	aa9fa55d-5d84-43c8-be0b-2548a63eb0e4	1	2018-03-08
71335-0117-4	EA - Each	71335-0117	f17599a2-91be-4522-a255-88be22d2d1aa	1	2018-03-08
71335-0117-5	EA - Each	71335-0117	ee55a031-418b-480b-88f7-00fbf015cfa2	1	2018-03-08
71335-0117-6	EA - Each	71335-0117	466707ea-fbb6-44e0-91b6-58d5a50d6de2	1	2018-03-08
71335-0117-7	EA - Each	71335-0117	8d25cf84-cc9b-43f1-b215-a2d0da5dfa52	1	2018-03-08
71335-0117-8	EA - Each	71335-0117	20c62b54-c6f3-41fa-bbd1-30042ce26ca3	1	2018-03-08
71335-0117-9	EA - Each	71335-0117	60ad105d-1d86-4617-b64e-cd46749e1474	1	2018-03-08

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0117-2	71335011702	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0117-2)	2022-09-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Orphenadrine Citrate Extended-Release Tablets, USP	Bryant Ranch Prepack	2022-09-28	HUMAN PRESCRIPTION DRUG LABEL	8