Chlordiazepoxide Hydrochloride

Product NDC: 42291-211
11-digit product format: 422910211
Labeler code: 42291
Product ID: 42291-211_98f90b71-98c9-043e-e053-2a95a90afb3e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlordiazepoxide Hydrochloride
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: AvKARE, Inc.
Application: ANDA085472
Marketing category: ANDA
Marketing start: 2011-03-14
Marketing end: 0000-00-00
Substance: CHLORDIAZEPOXIDE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42291-211		D	Discontinued by firm		2026-08-17
excluded package	package	42291-211	42291-211-90	D	Discontinued by firm		2026-08-17

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 · 24 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	42291-211-90	`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	42291-211-90	`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	42291-211-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42291-211-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42291-211-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42291-211-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42291-211-90	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42291-211-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42291-211-90	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42291-211-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42291-211-90	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42291-211-90	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A085472-001	LIBRIUM	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A085472-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085472-001	LIBRIUM	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A085472-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085472-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085472-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085472-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085472-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085472-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085472-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085472-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085472-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085472-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085472-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085472-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085472-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085472-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085472-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085472-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085472-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085472-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085472-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085472-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085472-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085472-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085472-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085472-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085472-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085472-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085472-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085472-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085472-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085472-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085472-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085472-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085472-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085472-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085472-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085472-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085472-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085472-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085472-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085472-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-211-90	EA - Each	42291-211	d3f25511-8c37-42e1-95e7-5244e0154799	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORDIAZEPOXIDE HYDROCHLORIDE	ACTIVE INGREDIENT	MFM6K1XWDK	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE, GELATIN COATED [AVKARE, INC.]	4
CHLORDIAZEPOXIDE	ACTIVE MOIETY	6RZ6XEZ3CR	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE, GELATIN COATED [AVKARE, INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE, GELATIN COATED [AVKARE, INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE, GELATIN COATED [AVKARE, INC.]	4
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE, GELATIN COATED [AVKARE, INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE, GELATIN COATED [AVKARE, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE, GELATIN COATED [AVKARE, INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE, GELATIN COATED [AVKARE, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE, GELATIN COATED [AVKARE, INC.]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE, GELATIN COATED [AVKARE, INC.]	4
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE, GELATIN COATED [AVKARE, INC.]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE, GELATIN COATED [AVKARE, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE, GELATIN COATED [AVKARE, INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE, GELATIN COATED [AVKARE, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE, GELATIN COATED [AVKARE, INC.]	4

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHLORDIAZEPOXIDE HYDROCHLORIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE	Epic Pharma, LLC	2e198c16-a929-4028-8f96-25dd23f74b10	2023-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085472 application number: ANDA085472
CHLORDIAZEPOXIDE HYDROCHLORIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE	Epic Pharma LLC	8255992f-3256-4558-bd0d-cfe350d95f25	2022-03-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085472 application number: ANDA085472

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MFM6K1XWDK	CHLORDIAZEPOXIDE HYDROCHLORIDE	438-41-5	CHLORDIAZEPOXIDE HYDROCHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES, USP C-IV	AvKARE, Inc.	2019-12-05	HUMAN PRESCRIPTION DRUG LABEL	9
Chlordiazepoxide Hydrochloride Capsules, USP Rx only	Aphena Pharma Solutions - Tennessee, LLC	2017-11-27	HUMAN PRESCRIPTION DRUG LABEL	3