ORPHENADRINE CITRATE

Product NDC: 53002-5430
11-digit product format: 530025430
Labeler code: 53002
Product ID: 53002-5430_ce37adfa-f4e3-4dfe-b9ca-212219aa4dff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ORPHENADRINE CITRATE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA040284
Marketing category: ANDA
Marketing start: 1998-06-19
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53002-5430		I	Inactivated by FDA	2026-08-03
excluded package	package	53002-5430	53002-5430-2	I	Inactivated by FDA	2026-08-03
excluded package	package	53002-5430	53002-5430-3	I	Inactivated by FDA	2026-08-03
excluded package	package	53002-5430	53002-5430-5	I	Inactivated by FDA	2026-08-03

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-5430-2	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-5430-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-5430-5	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-5430-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-5430-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-5430-5	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-5430-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-5430-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-5430-5	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-5430-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-5430-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-5430-5	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-5430-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-5430-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-5430-5	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-5430-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-5430-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-5430-5	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-5430-5	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-5430-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-5430-2	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-5430-5	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-5430-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-5430-2	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-5430-5	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-5430-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-5430-2	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A040284-001	ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1998-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040284-001	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	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1998-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1998-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1998-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1998-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1998-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1998-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1998-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1998-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1998-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1998-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1998-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1998-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1998-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1998-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1998-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1998-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1998-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040284-001	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-06-19	`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	A040284-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040284-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040284-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040284-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040284-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040284-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040284-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040284-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040284-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040284-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040284-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040284-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040284-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040284-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040284-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040284-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040284-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040284-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040284-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040284-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040284-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040284-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040284-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040284-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040284-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040284-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040284-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040284-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040284-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040284-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040284-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040284-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040284-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040284-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040284-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040284-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040284-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040284-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040284-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040284-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53002-5430-2	2025-01-30	C162847	48780-1	2cef2736-9063-d83d-e063-dadaa90ab31f	Orphenadrine Citrate Extended-Release Tablets Rx Only
53002-5430-3	2025-01-30	C162847	48780-1	2cef2736-9063-d83d-e063-dadaa90ab31f	Orphenadrine Citrate Extended-Release Tablets Rx Only
53002-5430-5	2025-01-30	C162847	48780-1	2cef2736-9063-d83d-e063-dadaa90ab31f	Orphenadrine Citrate Extended-Release Tablets Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-5430-2	ORPHENADRINE CITRATE	20 in 1 BOTTLE	TABLET, EXTENDED RELEASE	20	1
53002-5430-3	ORPHENADRINE CITRATE	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	1
53002-5430-5	ORPHENADRINE CITRATE	15 in 1 BOTTLE	TABLET, EXTENDED RELEASE	15	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-5430	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [RPK PHARMACEUTICALS, INC.]	1	Legacy NDC, 3 package rows	20220331_b9595be2-0872-4d42-98d5-ba6f23a48774.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Orphenadrine Citrate	ORPHENADRINE CITRATE	St. Mary's Medical Park Pharmacy	59000b66-166e-75d2-e053-2a91aa0af3c0	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040284 application number: ANDA040284
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	REMEDYREPACK INC.	7905e80f-b60b-48e8-8e63-a3e50211bfe4	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040284 application number: ANDA040284
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	Bryant Ranch Prepack	1b4e379e-8051-421f-a0f4-ad9e6fb9476a	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040284 application number: ANDA040284
Orphenadrine Citrate	ORPHENADRINE CITRATE	A-S Medication Solutions	80ef7fb4-7c50-4d25-915e-f9d4a2ccd199	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040284 application number: ANDA040284
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	PD-Rx Pharmaceuticals, Inc.	87d78229-f022-4b42-a03c-4e6a985c714f	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040284 application number: ANDA040284
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	Northwind Health Company, LLC	106be130-b4f8-5ca1-e063-6294a90a1590	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040284 application number: ANDA040284
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	Lupin Pharmaceuticals, Inc.	7b76c8a7-dd0c-481c-8299-26dfd38ce066	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040284 application number: ANDA040284
Orphenadrine Citrate	ORPHENADRINE CITRATE	Preferred Pharmaceuticals, Inc.	8ca9438d-320f-4499-aee7-6b8ca7cccc65	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040284 application number: ANDA040284
Orphenadrine Citrate ER	ORPHENADRINE CITRATE	Advanced Rx Pharmacy of Tennessee, LLC	b5a6846a-ebb3-1fdd-e053-2a95a90a4130	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040284 application number: ANDA040284
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	Advanced Rx Pharmacy of Tennessee, LLC	fc63d413-39bd-409d-e053-6294a90a1463	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040284 application number: ANDA040284
Orphenadrine Citrate	ORPHENADRINE CITRATE	Lake Erie Medical DBA Quality Care Products LLC	233915f1-7d58-4b4c-a2bb-e73179d61d07	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040284 application number: ANDA040284
Orphenadrine Citrate	ORPHENADRINE CITRATE	Bryant Ranch Prepack	8408d24e-3948-548d-bb12-b1edf0c05e12	2024-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040284 application number: ANDA040284
Orphenadrine Citrate	ORPHENADRINE CITRATE	NuCare Pharmaceuticals, Inc.	3eb1b1cc-ed7a-6f0f-e054-00144ff88e88	2024-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040284 application number: ANDA040284
Orphenadrine Citrate	ORPHENADRINE CITRATE	Proficient Rx LP	cf620257-7497-44c1-9853-87f96d262fbd	2023-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040284 application number: ANDA040284

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	b9595be2-0872-4d42-98d5-ba6f23a48774	1
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	b9595be2-0872-4d42-98d5-ba6f23a48774	1
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	b9595be2-0872-4d42-98d5-ba6f23a48774	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-5430-2	53002543002	20 TABLET, EXTENDED RELEASE in 1 BOTTLE (53002-5430-2)	2022-07-01	0000-00-00	No	No	Current
53002-5430-3	53002543003	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (53002-5430-3)	2022-07-01	0000-00-00	No	No	Current
53002-5430-5	53002543005	15 TABLET, EXTENDED RELEASE in 1 BOTTLE (53002-5430-5)	2022-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Orphenadrine Citrate Extended-Release Tablets Rx Only	RPK Pharmaceuticals, Inc.	2022-03-30	HUMAN PRESCRIPTION DRUG LABEL	1