Orphenadrine Citrate

Product NDC: 49999-046
11-digit product format: 499990046
Labeler code: 49999
Product ID: 49999-046_018c5bb2-b5ea-4e62-8670-3e099c32ead9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Orphenadrine Citrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: ANDA040284
Marketing category: ANDA
Marketing start: 2011-02-07
Marketing end: 2026-11-30
Substance: ORPHENADRINE CITRATE
Active strength: 100 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag: No
Current FDA listing: Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	49999-046	49999-046-14	D	Discontinued by firm	2026-08-07
excluded package	package	49999-046	49999-046-30	D	Discontinued by firm	2026-08-07
excluded package	package	49999-046	49999-046-90	D	Discontinued by firm	2026-08-07

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 · 27 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	49999-046-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	49999-046-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	49999-046-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	49999-046-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	49999-046-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	49999-046-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	49999-046-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	49999-046-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	49999-046-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	49999-046-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	49999-046-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	49999-046-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	49999-046-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	49999-046-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	49999-046-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	49999-046-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	49999-046-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	49999-046-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	49999-046-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	49999-046-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	49999-046-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	49999-046-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	49999-046-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	49999-046-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	49999-046-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	49999-046-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	49999-046-30	`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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Orphenadrine Citrate

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
233915f1-7d58-4b4c-a2bb-e73179d61d07	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49999-046-14	Orphenadrine Citrate	14 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	14	3227
49999-046-30	Orphenadrine Citrate	30 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	30	3227
49999-046-60	Orphenadrine Citrate	60 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	60	3227
49999-046-90	Orphenadrine Citrate	90 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	90	3227

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49999-046-14	EA - Each	49999-046	cb7add87-1e7a-491f-aed2-6fe732cb2f65	1	2012-07-24
49999-046-30	EA - Each	49999-046	9c4ade31-11e6-4dc3-8395-183b2019f93e	1	2012-07-24
49999-046-60	EA - Each	49999-046	ad058912-e2dc-4dc3-85c5-ab6b719e2f59	1	2018-07-03
49999-046-90	EA - Each	49999-046	e8927f55-61a6-4d58-97ae-c173ef0311ad	1	2018-07-03

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49999-046	ORPHENADRINE CITRATE (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3227	Current NDC, Legacy NDC, 4 package rows	20241218_233915f1-7d58-4b4c-a2bb-e73179d61d07.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 ndc (product): 49999-046
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49999-046-14	49999004614	14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49999-046-14)	2011-02-07	0000-00-00	No	No	Current
49999-046-30	49999004630	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49999-046-30)	2011-02-07	0000-00-00	No	No	Current
49999-046-60	49999004660	60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49999-046-60)	2011-02-07	2026-11-30	No	No	Current
49999-046-90	49999004690	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49999-046-90)	2018-06-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Orphenadrine Citrate Extended-Release Tablets	Lake Erie Medical DBA Quality Care Products LLC	2024-12-16	HUMAN PRESCRIPTION DRUG LABEL	3227