ORPHENADRINE CITRATE

Product NDC: 43386-480
11-digit product format: 433860480
Labeler code: 43386
Product ID: 43386-480_e80ecc89-bd45-4796-850b-c379a79ac7ab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ORPHENADRINE CITRATE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA040284
Marketing category: ANDA
Marketing start: 1998-06-19
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
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…`

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
7b76c8a7-dd0c-481c-8299-26dfd38ce066	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43386-480-24	ORPHENADRINE CITRATE	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	15
43386-480-26	ORPHENADRINE CITRATE	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	15
43386-480-28	ORPHENADRINE CITRATE	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43386-480-24	EA - Each	43386-480	8ccb1483-ff37-40d2-b813-aa0371fd73c4	1	2012-07-24
43386-480-26	EA - Each	43386-480	2ae8c74b-0d50-4c30-876c-45313a325974	1	2012-07-24
43386-480-28	EA - Each	43386-480	d2582543-494d-42eb-a3b1-8d5943b6c758	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ORPHENADRINE CITRATE	ACTIVE INGREDIENT	X0A40N8I4S	ORPHENADRINE CITRATE (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3221
ORPHENADRINE	ACTIVE MOIETY	AL805O9OG9	ORPHENADRINE CITRATE (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3221
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ORPHENADRINE CITRATE (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3221
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ORPHENADRINE CITRATE (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3221
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ORPHENADRINE CITRATE (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3221
ORPHENADRINE CITRATE	ACTIVE INGREDIENT	X0A40N8I4S	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	16
ORPHENADRINE	ACTIVE MOIETY	AL805O9OG9	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	16
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	16
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	16
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	16
ORPHENADRINE CITRATE	ACTIVE INGREDIENT	X0A40N8I4S	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [GAVIS PHARMACEUTICALS, LLC]	12
ORPHENADRINE	ACTIVE MOIETY	AL805O9OG9	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [GAVIS PHARMACEUTICALS, LLC]	12
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [GAVIS PHARMACEUTICALS, LLC]	12
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [GAVIS PHARMACEUTICALS, LLC]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [GAVIS PHARMACEUTICALS, LLC]	12
ORPHENADRINE CITRATE	ACTIVE INGREDIENT	X0A40N8I4S	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	3
ORPHENADRINE	ACTIVE MOIETY	AL805O9OG9	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	3
ORPHENADRINE CITRATE	ACTIVE INGREDIENT	X0A40N8I4S	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [RXCHANGE CO.]	2
ORPHENADRINE CITRATE	ACTIVE INGREDIENT	X0A40N8I4S	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]	2
ORPHENADRINE CITRATE	ACTIVE INGREDIENT	X0A40N8I4S	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DIRECT RX]	2
ORPHENADRINE CITRATE	ACTIVE INGREDIENT	X0A40N8I4S	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
ORPHENADRINE CITRATE	ACTIVE INGREDIENT	X0A40N8I4S	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	2
ORPHENADRINE	ACTIVE MOIETY	AL805O9OG9	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [RXCHANGE CO.]	2
ORPHENADRINE	ACTIVE MOIETY	AL805O9OG9	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]	2
ORPHENADRINE	ACTIVE MOIETY	AL805O9OG9	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
ORPHENADRINE	ACTIVE MOIETY	AL805O9OG9	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DIRECT RX]	2
ORPHENADRINE	ACTIVE MOIETY	AL805O9OG9	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [RXCHANGE CO.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DIRECT RX]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DIRECT RX]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [RXCHANGE CO.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [RXCHANGE CO.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DIRECT RX]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
ORPHENADRINE CITRATE	ACTIVE INGREDIENT	X0A40N8I4S	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC]	1
ORPHENADRINE CITRATE	ACTIVE INGREDIENT	X0A40N8I4S	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	1
ORPHENADRINE CITRATE	ACTIVE INGREDIENT	X0A40N8I4S	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
ORPHENADRINE CITRATE	ACTIVE INGREDIENT	X0A40N8I4S	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
ORPHENADRINE CITRATE	ACTIVE INGREDIENT	X0A40N8I4S	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
ORPHENADRINE	ACTIVE MOIETY	AL805O9OG9	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
ORPHENADRINE	ACTIVE MOIETY	AL805O9OG9	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
ORPHENADRINE	ACTIVE MOIETY	AL805O9OG9	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
ORPHENADRINE	ACTIVE MOIETY	AL805O9OG9	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC]	1
ORPHENADRINE	ACTIVE MOIETY	AL805O9OG9	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43386-480	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	14	Current NDC, Legacy NDC, 3 package rows	20190226_7b76c8a7-dd0c-481c-8299-26dfd38ce066.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 ndc (product): 43386-480
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	233915f1-7d58-4b4c-a2bb-e73179d61d07	3227
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	233915f1-7d58-4b4c-a2bb-e73179d61d07	3227
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	233915f1-7d58-4b4c-a2bb-e73179d61d07	3227
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	1b4e379e-8051-421f-a0f4-ad9e6fb9476a	103
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	1b4e379e-8051-421f-a0f4-ad9e6fb9476a	103
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	1b4e379e-8051-421f-a0f4-ad9e6fb9476a	103
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	87d78229-f022-4b42-a03c-4e6a985c714f	35
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	87d78229-f022-4b42-a03c-4e6a985c714f	35
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	87d78229-f022-4b42-a03c-4e6a985c714f	35
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	80ef7fb4-7c50-4d25-915e-f9d4a2ccd199	19
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	8408d24e-3948-548d-bb12-b1edf0c05e12	19
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	8408d24e-3948-548d-bb12-b1edf0c05e12	19
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	80ef7fb4-7c50-4d25-915e-f9d4a2ccd199	19
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	80ef7fb4-7c50-4d25-915e-f9d4a2ccd199	19
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	8408d24e-3948-548d-bb12-b1edf0c05e12	19
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	7b76c8a7-dd0c-481c-8299-26dfd38ce066	15
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	7b76c8a7-dd0c-481c-8299-26dfd38ce066	15
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	7b76c8a7-dd0c-481c-8299-26dfd38ce066	15
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	8ca9438d-320f-4499-aee7-6b8ca7cccc65	13
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	8ca9438d-320f-4499-aee7-6b8ca7cccc65	13
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	8ca9438d-320f-4499-aee7-6b8ca7cccc65	13
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	59000b66-166e-75d2-e053-2a91aa0af3c0	7
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	59000b66-166e-75d2-e053-2a91aa0af3c0	7
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	59000b66-166e-75d2-e053-2a91aa0af3c0	7
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	cf620257-7497-44c1-9853-87f96d262fbd	6
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	b5a6846a-ebb3-1fdd-e053-2a95a90a4130	6
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	b5a6846a-ebb3-1fdd-e053-2a95a90a4130	6
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	cf620257-7497-44c1-9853-87f96d262fbd	6
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	b5a6846a-ebb3-1fdd-e053-2a95a90a4130	6
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	cf620257-7497-44c1-9853-87f96d262fbd	6
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	3eb1b1cc-ed7a-6f0f-e054-00144ff88e88	5
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	91436f1e-8b05-435c-e053-2a95a90ae21f	5
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	3eb1b1cc-ed7a-6f0f-e054-00144ff88e88	5
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	91436f1e-8b05-435c-e053-2a95a90ae21f	5
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	3eb1b1cc-ed7a-6f0f-e054-00144ff88e88	5
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	91436f1e-8b05-435c-e053-2a95a90ae21f	5
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	41605713-726c-5a57-e054-00144ff88e88	4
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	41605713-726c-5a57-e054-00144ff88e88	4
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	41605713-726c-5a57-e054-00144ff88e88	4
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	7905e80f-b60b-48e8-8e63-a3e50211bfe4	3
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	fc63d413-39bd-409d-e053-6294a90a1463	3
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	8a258480-2f47-4b62-850c-1beed383ba29	3
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	8a258480-2f47-4b62-850c-1beed383ba29	3
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	fc63d413-39bd-409d-e053-6294a90a1463	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	fc63d413-39bd-409d-e053-6294a90a1463	3
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	7905e80f-b60b-48e8-8e63-a3e50211bfe4	3
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	8a258480-2f47-4b62-850c-1beed383ba29	3
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	68520968-23bb-6ae9-e053-2991aa0a773d	2
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	106be130-b4f8-5ca1-e063-6294a90a1590	2
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	c8dcda72-efd3-4203-8cc3-f6121cfdd5b0	2
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	b32eb120-fbc3-4ef0-b418-3d1739130475	2
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	b32eb120-fbc3-4ef0-b418-3d1739130475	2
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	c8dcda72-efd3-4203-8cc3-f6121cfdd5b0	2
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	106be130-b4f8-5ca1-e063-6294a90a1590	2
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	68520968-23bb-6ae9-e053-2991aa0a773d	2
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	b32eb120-fbc3-4ef0-b418-3d1739130475	2
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	106be130-b4f8-5ca1-e063-6294a90a1590	2
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	68520968-23bb-6ae9-e053-2991aa0a773d	2
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	c8dcda72-efd3-4203-8cc3-f6121cfdd5b0	2
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	19b31a8f-d07e-43df-a0f0-a9b34406c904	1
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	11a33d71-ca38-2da0-e054-00144ff8d46c	1
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	28d5753e-862a-4811-8b9f-6707361f8475	1
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	0f50125a-6d89-4b2b-b48b-daac6129182c	1
994521	orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet	PSN	34769dda-f555-460e-9064-98ab205393c5	1
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	19b31a8f-d07e-43df-a0f0-a9b34406c904	1
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	0f50125a-6d89-4b2b-b48b-daac6129182c	1
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	34769dda-f555-460e-9064-98ab205393c5	1
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	b9595be2-0872-4d42-98d5-ba6f23a48774	1
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	11a33d71-ca38-2da0-e054-00144ff8d46c	1
994521	12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet	SCD	28d5753e-862a-4811-8b9f-6707361f8475	1
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	b9595be2-0872-4d42-98d5-ba6f23a48774	1
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	34769dda-f555-460e-9064-98ab205393c5	1
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	11a33d71-ca38-2da0-e054-00144ff8d46c	1
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	0f50125a-6d89-4b2b-b48b-daac6129182c	1
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	28d5753e-862a-4811-8b9f-6707361f8475	1
994521	orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet	SY	19b31a8f-d07e-43df-a0f0-a9b34406c904	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43386-480-24	43386048024	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-24)	1998-06-19	0000-00-00	No	No	Current
43386-480-26	43386048026	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-26)	1998-06-19	0000-00-00	No	No	Current
43386-480-28	43386048028	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-28)	1998-06-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Orphenadrine Citrate Extended-Release Tablets Gavis Pharmaceuticals, LLC.	St. Mary's Medical Park Pharmacy	2026-06-26	HUMAN PRESCRIPTION DRUG LABEL	8
Orphenadrine Citrate Extended-Release Tablets Rx Only	REMEDYREPACK INC.	2026-04-28	HUMAN PRESCRIPTION DRUG LABEL	3
Orphenadrine Citrate Extended-Release Tablets Rx Only	Bryant Ranch Prepack	2026-02-26	HUMAN PRESCRIPTION DRUG LABEL	103
Orphenadrine Citrate Extended-Release Tablets Rx Only	A-S Medication Solutions	2026-01-20	HUMAN PRESCRIPTION DRUG LABEL	19
Orphenadrine Citrate Extended-Release Tablets Rx Only	PD-Rx Pharmaceuticals, Inc.	2026-01-07	HUMAN PRESCRIPTION DRUG LABEL	35
Orphenadrine Citrate Extended-Release Tablets Rx Only	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	2
Orphenadrine Citrate Extended-Release Tablets Rx Only	Lupin Pharmaceuticals, Inc. \| Lupin, Inc. \| Novel Laboratories, Inc.	2025-09-10	HUMAN PRESCRIPTION DRUG LABEL	15
Orphenadrine Citrate Extended-Release Tablets Rx Only	Preferred Pharmaceuticals, Inc.	2025-09-04	HUMAN PRESCRIPTION DRUG LABEL	13
Orphenadrine Citrate ER Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	6
Orphenadrine Citrate Extended-Release Tablets Rx Only	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	3
Orphenadrine Citrate Extended-Release Tablets	Lake Erie Medical DBA Quality Care Products LLC	2024-12-16	HUMAN PRESCRIPTION DRUG LABEL	3227
Orphenadrine Citrate Extended-Release Tablets Rx Only	Bryant Ranch Prepack	2024-08-27	HUMAN PRESCRIPTION DRUG LABEL	19
Orphenadrine Citrate Extended-Release Tablets Gavis Pharmaceuticals, LLC.	NuCare Pharmaceuticals, Inc.	2024-08-13	HUMAN PRESCRIPTION DRUG LABEL	5
Orphenadrine Citrate - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-07-11	HUMAN PRESCRIPTION DRUG LABEL	4
Orphenadrine Citrate	Direct_Rx	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	5
Orphenadrine Citrate Extended-Release Tablets	Proficient Rx LP	2023-12-01	HUMAN PRESCRIPTION DRUG LABEL	6
Orphenadrine Citrate Extended-Release Tablets Rx Only	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL	2
Orphenadrine Citrate Extended-Release Tablets Rx Only	RPK Pharmaceuticals, Inc.	2022-03-30	HUMAN PRESCRIPTION DRUG LABEL	1
ORPHENADRINE CITRATE	DIRECT RX	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	2