ORPHENADRINE CITRATE

Product NDC: 70518-4506
Requested package NDC: 70518-4506-2
11-digit product format: 705184506
Labeler code: 70518
Product ID: 70518-4506_508a41a9-403b-e409-e063-6294a90ad6fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ORPHENADRINE CITRATE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA040284
Marketing category: ANDA
Marketing start: 2025-10-15
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: 2027-12-31
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
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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (package): 70518-4506-2 ndc (product): 70518-4506 ndc11 (package): 70518450602
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

Additional Listing Data#

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

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
7905e80f-b60b-48e8-8e63-a3e50211bfe4	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-4506-0	ORPHENADRINE CITRATE	14 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	14	3
70518-4506-1	ORPHENADRINE CITRATE	14 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	14	3
70518-4506-2	ORPHENADRINE CITRATE	50 in 1 BOX	TABLET, EXTENDED RELEASE	50	3
70518-4506-3	ORPHENADRINE CITRATE	1 in 1 POUCH	TABLET, EXTENDED RELEASE	1	3

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	7905e80f-b60b-48e8-8e63-a3e50211bfe4	3
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	7905e80f-b60b-48e8-8e63-a3e50211bfe4	3
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	7905e80f-b60b-48e8-8e63-a3e50211bfe4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4506-2	70518450602	50 POUCH in 1 BOX (70518-4506-2) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4506-3)	50 pouch	2026-04-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Orphenadrine Citrate Extended-Release Tablets Rx Only	REMEDYREPACK INC.	2026-04-28	HUMAN PRESCRIPTION DRUG LABEL	3