TIZANIDINE HYDROCHLORIDE

Product NDC: 61919-196
Requested package NDC: 61919-196-72
11-digit product format: 619190196
Labeler code: 61919
Product ID: 61919-196_4c484458-33e2-e0cc-e063-6294a90a9e28
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TIZANIDINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: TIZANIDINE HYDROCHLORIDE
Application: ANDA091283
Marketing category: ANDA
Marketing start: 2014-01-01
Substance: TIZANIDINE HYDROCHLORIDE
Active strength: 4 mg/1
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091283-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2012-11-28
A091283-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2012-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091283-001	AB
A091283-002	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	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`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	A091283-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091283-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091283-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091283-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091283-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091283-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091283-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091283-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091283-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091283-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091283-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091283-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091283-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091283-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091283-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091283-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091283-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091283-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091283-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091283-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091283-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091283-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091283-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091283-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091283-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091283-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091283-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091283-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091283-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091283-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091283-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091283-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091283-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091283-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091283-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091283-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091283-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091283-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091283-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091283-002	AB	1	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tizanidine	TIZANIDINE	NuCare Pharmaceuticals,Inc.	6dd9946f-b2a4-1732-e053-2a91aa0a648f	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	REMEDYREPACK INC.	b14bd166-9f53-4f2e-be05-c447af04ef69	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	047c67cd-7a63-49c9-b100-71651d3537ba	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283 ndc (package): 61919-196-72 ndc (product): 61919-196 ndc11 (package): 61919019672
TIZANDINE	TIZANDINE	Direct_Rx	9003cb5d-f9d6-7183-e053-2995a90ad6e8	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	A-S Medication Solutions	308d2fdc-6136-4e75-95d3-342497add66c	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	A-S Medication Solutions	9fd932fb-033c-4774-ac09-c823db8f9739	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	Redpharm Drug	49adcfc8-3b1d-7f7e-e063-6294a90a361e	2026-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	PD-Rx Pharmaceuticals, Inc.	615dfd5c-125a-40e2-a6da-afacde305282	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	Unichem Pharmaceuticals (USA), Inc.	a3fa9c69-4baf-44f5-bac4-a19c34b0e1cb	2025-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	A-S Medication Solutions	9678a98e-4aab-4d87-b5e1-37c3109e378e	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	Bryant Ranch Prepack	f87e30ce-a60a-41e3-b5d6-7e2966143961	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	Preferred Pharmaceuticals Inc.	6e97c1ba-8171-4707-98ee-61afed75daac	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine HCL	TIZANIDINE HCL	Advanced Rx of Tennessee, LLC	afc96ee6-c99b-7283-e053-2a95a90ad14d	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	Advanced Rx Pharmacy of Tennessee, LLC	d2961d1c-5de2-0a2b-e053-2995a90ad2fc	2024-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	Proficient Rx LP	e13b111a-25b7-4fdd-a102-30f2996722f3	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	Proficient Rx LP	5b7b4721-e6fa-4586-ac40-091ad363ee85	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	Aphena Pharma Solutions - Tennessee, LLC	ea242c7d-b101-4197-8e65-b2b079e3b2b6	2019-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283

Additional Listing Data#

Finished product: Yes
Brand name base: TIZANIDINE HYDROCHLORIDE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIZANIDINE HYDROCHLORIDE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
B53E3NMY5C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313413	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
047c67cd-7a63-49c9-b100-71651d3537ba	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a0ff02d8-b711-423c-b7d1-ada00d81c743	Product name	1	20250805
9fd28b3a-d1bb-a2ce-ffa3-c3dd28536a01	Product name	8	20250313
b404127e-1c01-47bb-874e-db1e0b6bd9af	Product name	4	20250313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-196-30	2025-01-30	C162847	48780-1	2cef2736-8331-d83d-e063-dadaa90ab31f	TIZANIDINE HYDROCHLORIDE
61919-196-40	2025-01-30	C162847	48780-1	2cef2736-8331-d83d-e063-dadaa90ab31f	TIZANIDINE HYDROCHLORIDE
61919-196-60	2025-01-30	C162847	48780-1	2cef2736-8331-d83d-e063-dadaa90ab31f	TIZANIDINE HYDROCHLORIDE
61919-196-72	2025-01-30	C162847	48780-1	2cef2736-8331-d83d-e063-dadaa90ab31f	TIZANIDINE HYDROCHLORIDE
61919-196-90	2025-01-30	C162847	48780-1	2cef2736-8331-d83d-e063-dadaa90ab31f	TIZANIDINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-196-20	TIZANIDINE HYDROCHLORIDE	20 in 1 BOTTLE	TABLET	20	7
61919-196-30	TIZANIDINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30	7
61919-196-40	TIZANIDINE HYDROCHLORIDE	40 in 1 BOTTLE	TABLET	40	7
61919-196-60	TIZANIDINE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET	60	7
61919-196-72	TIZANIDINE HYDROCHLORIDE	72 in 1 BOTTLE	TABLET	72	7
61919-196-90	TIZANIDINE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-196-30	EA - Each	61919-196	d9738507-dea3-4be7-b22f-54f870b42815	1	2015-04-03
61919-196-40	EA - Each	61919-196	531d7162-f55a-4f54-97fb-dc6d3a53d617	1	2021-07-15
61919-196-60	EA - Each	61919-196	3c5664c8-e3b7-49a1-b452-6250761e780c	1	2015-04-03
61919-196-72	EA - Each	61919-196	398afc75-eec5-4737-90e2-35b0d20222cb	1	2015-04-03
61919-196-90	EA - Each	61919-196	3e8bbb6b-c8c9-4c8b-81ef-dd2fc12dc442	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TIZANIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	B53E3NMY5C	TIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]	1
TIZANIDINE	ACTIVE MOIETY	6AI06C00GW	TIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-196	TIZANIDINE HYDROCHLORIDE TABLET [TIZANIDINE HYDROCHLORIDE]	6	Current NDC, Legacy NDC, 6 package rows	20230413_047c67cd-7a63-49c9-b100-71651d3537ba.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B53E3NMY5C	TIZANIDINE HYDROCHLORIDE	64461-82-1	TIZANIDINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	047c67cd-7a63-49c9-b100-71651d3537ba	7
313413	tizanidine 4 MG Oral Tablet	SCD	047c67cd-7a63-49c9-b100-71651d3537ba	7
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	047c67cd-7a63-49c9-b100-71651d3537ba	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-196-72	61919019672	72 TABLET in 1 BOTTLE (61919-196-72)	72 tablet	2015-01-01	0000-00-00	No	No	Current