Cyclobenzaprine Hydrochloride

Product NDC: 12634-528
11-digit product format: 126340528
Labeler code: 12634
Product ID: 12634-528_27fe4bb9-282f-42ca-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Apotheca Inc.
Application: ANDA090478
Marketing category: ANDA
Marketing start: 2012-04-02
Marketing end: 0000-00-00
Substance: CYCLOBENZAPRINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 24 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-528		I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-00	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-01	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-52	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-54	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-57	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-59	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-60	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-61	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-63	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-66	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-67	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-69	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-71	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-74	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-78	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-80	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-81	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-82	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-85	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-91	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-94	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-95	I	Inactivated by FDA	2026-08-11
excluded package	package	12634-528	12634-528-96	I	Inactivated by FDA	2026-08-11

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 9 · 504 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-69	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-67	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-63	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-74	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-528-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-52	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-82	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-81	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-69	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-67	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-63	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-66	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-74	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-528-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-528-52	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-528-82	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-528-81	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-528-95	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-528-69	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-528-78	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-528-61	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-528-67	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-528-54	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-528-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-528-94	`2ef7874e63bc…`	`57b86245f4fa…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2010-07-23
A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2010-07-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090478-001	AB
A090478-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A090478-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090478-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090478-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090478-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090478-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090478-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090478-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090478-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090478-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090478-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090478-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090478-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090478-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090478-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090478-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090478-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090478-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090478-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090478-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090478-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090478-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090478-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090478-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090478-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090478-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090478-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090478-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090478-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090478-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090478-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090478-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090478-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090478-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090478-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090478-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090478-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090478-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090478-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090478-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090478-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
51048710-225c-aa41-d0e7-eed095d02838	Product name	4	20250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515ee	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
12634-528-00	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-01	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-52	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-54	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-57	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-59	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-60	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-61	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-63	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-66	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-67	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-69	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-71	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-74	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-78	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-80	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-81	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-82	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-85	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-91	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-94	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-95	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-96	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-528-00	Cyclobenzaprine Hydrochloride	10 in 1 BOTTLE	TABLET	10	5
12634-528-01	Cyclobenzaprine Hydrochloride	100 in 1 BOTTLE	TABLET	100	5
12634-528-52	Cyclobenzaprine Hydrochloride	12 in 1 BLISTER PACK	TABLET	12	5
12634-528-54	Cyclobenzaprine Hydrochloride	14 in 1 BLISTER PACK	TABLET	14	5
12634-528-57	Cyclobenzaprine Hydrochloride	20 in 1 BLISTER PACK	TABLET	20	5
12634-528-59	Cyclobenzaprine Hydrochloride	30 in 1 BLISTER PACK	TABLET	30	5
12634-528-60	Cyclobenzaprine Hydrochloride	60 in 1 BOTTLE	TABLET	60	5
12634-528-61	Cyclobenzaprine Hydrochloride	10 in 1 BLISTER PACK	TABLET	10	5
12634-528-63	Cyclobenzaprine Hydrochloride	3 in 1 BLISTER PACK	TABLET	3	5
12634-528-66	Cyclobenzaprine Hydrochloride	6 in 1 BLISTER PACK	TABLET	6	5
12634-528-67	Cyclobenzaprine Hydrochloride	7 in 1 BLISTER PACK	TABLET	7	5
12634-528-69	Cyclobenzaprine Hydrochloride	9 in 1 BLISTER PACK	TABLET	9	5
12634-528-71	Cyclobenzaprine Hydrochloride	30 in 1 BOTTLE	TABLET	30	5
12634-528-74	Cyclobenzaprine Hydrochloride	24 in 1 BOTTLE	TABLET	24	5
12634-528-78	Cyclobenzaprine Hydrochloride	28 in 1 BOTTLE	TABLET	28	5
12634-528-80	Cyclobenzaprine Hydrochloride	20 in 1 BOTTLE	TABLET	20	5
12634-528-81	Cyclobenzaprine Hydrochloride	21 in 1 BOTTLE	TABLET	21	5
12634-528-82	Cyclobenzaprine Hydrochloride	12 in 1 BOTTLE	TABLET	12	5
12634-528-85	Cyclobenzaprine Hydrochloride	15 in 1 BOTTLE	TABLET	15	5
12634-528-91	Cyclobenzaprine Hydrochloride	1 in 1 BLISTER PACK	TABLET	1	5
12634-528-94	Cyclobenzaprine Hydrochloride	4 in 1 BOTTLE	TABLET	4	5
12634-528-95	Cyclobenzaprine Hydrochloride	5 in 1 BOTTLE	TABLET	5	5
12634-528-96	Cyclobenzaprine Hydrochloride	6 in 1 BOTTLE	TABLET	6	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
12634-528-00	EA - Each	12634-528	15fb067a-e3c3-4fea-9d84-c5c590a491d0	1	2016-01-13
12634-528-60	EA - Each	12634-528	b0d870f2-93db-41a7-a9e5-7f2775b4a8b5	1	2016-01-13
12634-528-71	EA - Each	12634-528	ed4fe9fc-4ec2-49dd-88b6-877a754a75dc	1	2016-01-13
12634-528-81	EA - Each	12634-528	4ab8220b-5b0e-446a-9c7e-f476e32a9a92	1	2016-01-13
12634-528-85	EA - Each	12634-528	645c3ebe-d4b7-4bed-b03d-61b0bf0b29b3	1	2016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-528	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [APOTHECA INC.]	5	Legacy NDC, 23 package rows	20151229_27327397-3ff7-6e43-e054-00144ff88e88.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Cipla USA Inc.	575a31fb-04c5-4001-88a7-c33adbacc6a8	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	NuCare Pharmaceuticals, Inc.	4fbbc5b6-7aac-34e5-e054-00144ff88e88	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	NuCare Pharmaceuticals, Inc.	4a2b5f25-a333-15f3-e054-00144ff8d46c	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Northwind Health Company, LLC	e04eea45-12ec-4d2b-e053-2a95a90a6b76	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	American Health Packaging	269bc278-963d-4830-816a-39bb4bf8c936	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	AvPAK	64f6d1be-4067-a5c7-2343-4aed651a0cac	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	AvPAK	e530fd1e-06fd-0432-e053-2995a90adf5f	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Aphena Pharma Solutions - Tennessee, LLC	3bc7e2b4-e1a0-66e3-e063-6294a90a676a	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	EXELAN PHARMACEUTICALS, INC.	cf81da00-7c6d-4477-bb70-b3c2abea177a	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	NCS HealthCare of KY, LLC dba Vangard Labs	53688de9-2031-4d19-b422-4000285f7f47	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Proficient Rx LP	ae6de8d8-33c2-40bd-9dd3-782c879a9d8f	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE	6202-23-9	CYCLOBENZAPRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	27327397-3ff7-6e43-e054-00144ff88e88	5
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	27327397-3ff7-6e43-e054-00144ff88e88	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-528-00	12634052800	10 in 1 BOTTLE	Historical
12634-528-01	12634052801	100 in 1 BOTTLE	Historical
12634-528-52	12634052852	12 in 1 BLISTER PACK	Historical
12634-528-54	12634052854	14 in 1 BLISTER PACK	Historical
12634-528-57	12634052857	20 in 1 BLISTER PACK	Historical
12634-528-59	12634052859	30 in 1 BLISTER PACK	Historical
12634-528-60	12634052860	60 in 1 BOTTLE	Historical
12634-528-61	12634052861	10 in 1 BLISTER PACK	Historical
12634-528-63	12634052863	3 in 1 BLISTER PACK	Historical
12634-528-66	12634052866	6 in 1 BLISTER PACK	Historical
12634-528-67	12634052867	7 in 1 BLISTER PACK	Historical
12634-528-69	12634052869	9 in 1 BLISTER PACK	Historical
12634-528-71	12634052871	30 in 1 BOTTLE	Historical
12634-528-74	12634052874	24 in 1 BOTTLE	Historical
12634-528-78	12634052878	28 in 1 BOTTLE	Historical
12634-528-80	12634052880	20 in 1 BOTTLE	Historical
12634-528-81	12634052881	21 in 1 BOTTLE	Historical
12634-528-82	12634052882	12 in 1 BOTTLE	Historical
12634-528-85	12634052885	15 in 1 BOTTLE	Historical
12634-528-91	12634052891	1 in 1 BLISTER PACK	Historical
12634-528-94	12634052894	4 in 1 BOTTLE	Historical
12634-528-95	12634052895	5 in 1 BOTTLE	Historical
12634-528-96	12634052896	6 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP	Apotheca Inc.	2015-12-28	HUMAN PRESCRIPTION DRUG LABEL	5