Fossaoprin SPG4

Product NDC: 70529-018
Requested package NDC: 70529-018-01
11-digit product format: 705290018
Labeler code: 70529
Product ID: 70529-018_111572c2-3009-4a36-b651-328537b313d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine hydrochloride, Bupivacaine hydrochloride
Dosage form: KIT
Labeler: IT3 Medical LLC
Application: ANDA088295
Marketing category: ANDA
Marketing start: 2017-03-01
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70529-018	70529-018-01	I	Inactivated by FDA		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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088295-001	AP

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION		RS	1984-05-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION		RS	1984-05-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION		RS	1984-05-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION		RS	1984-05-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION		RS	1984-05-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION		RS	1984-05-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION		RS	1984-05-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION		RS	1984-05-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION		RS	1984-05-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION		RS	1984-05-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION		RS	1984-05-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION		RS	1984-05-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088295-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	INJECTABLE / INJECTION	AP	RS	1984-05-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A088295-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088295-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088295-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088295-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088295-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088295-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088295-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088295-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088295-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088295-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088295-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088295-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088295-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088295-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088295-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088295-001	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088295-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088295-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088295-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088295-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088295-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088295-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088295-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088295-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088295-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088295-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088295-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088295-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088295-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A088295-001	AP	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435	Product name	2	20250303
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
e3a99641-4540-4894-9108-00cab3c57b7e	Product name	1	20211207
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
5da98533-f072-406b-9e1b-6ac19eca9926	Product name	1	20210622
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
306b993e-3140-4823-ad5e-88b708f9d2ac	Product name	1	20210510
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
a831e694-3663-4a83-82be-6c309429f750	Product name	2	20200608
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70529-018-01	2023-07-28	C162847	48780-1	d6a99b39-370d-a426-e053-dadaa90af4c2	Fossaoprin SPG4 Injection System
70529-018-01	2022-03-01	C162847	48780-1	d6a99b39-370d-a426-e053-dadaa90af4c2	Fossaoprin SPG4 Injection System
70529-018-01	2022-01-28	C162847	48780-1	d6a99b39-370d-a426-e053-dadaa90af4c2	Fossaoprin SPG4 Injection System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70529-018-01	Fossaoprin SPG4	1 in 1 PACKAGE	KIT	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70529-018	FOSSAOPRIN SPG4 (LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE) KIT [IT3 MEDICAL LLC]	3	Legacy NDC, 1 package rows	20220302_0029ecd1-a700-46a5-a5f9-c416fb2bb4f0.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	89a4bd73-89f4-4fd7-2c9f-921e1da8f96b	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088295 application number: ANDA088295
LIDOCAINE HCl	LIDOCAINE HCL	HF Acquisition Co LLC, DBA HealthFirst	e8bc96bc-7876-4906-e053-2a95a90ae6ba	2024-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088295 application number: ANDA088295

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1012404	BUPivacaine HCl 0.5 % Injectable Solution	PSN	0029ecd1-a700-46a5-a5f9-c416fb2bb4f0	3
797544	isopropyl alcohol 70 % Medicated Pad	PSN	0029ecd1-a700-46a5-a5f9-c416fb2bb4f0	3
1010844	lidocaine HCl 4 % in 5 ML Injection	PSN	0029ecd1-a700-46a5-a5f9-c416fb2bb4f0	3
1012406	Marcaine 0.5 % Injectable Solution	PSN	0029ecd1-a700-46a5-a5f9-c416fb2bb4f0	3
1012406	bupivacaine hydrochloride 5 MG/ML Injectable Solution [Marcaine]	SBD	0029ecd1-a700-46a5-a5f9-c416fb2bb4f0	3
1010844	5 ML lidocaine hydrochloride 40 MG/ML Injection	SCD	0029ecd1-a700-46a5-a5f9-c416fb2bb4f0	3
1012404	bupivacaine hydrochloride 5 MG/ML Injectable Solution	SCD	0029ecd1-a700-46a5-a5f9-c416fb2bb4f0	3
797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	0029ecd1-a700-46a5-a5f9-c416fb2bb4f0	3
1012404	bupivacaine hydrochloride 0.5 % Injectable Solution	SY	0029ecd1-a700-46a5-a5f9-c416fb2bb4f0	3
797544	isopropyl alcohol 70 % Medicated Pad	SY	0029ecd1-a700-46a5-a5f9-c416fb2bb4f0	3
797544	isopropyl alcohol 70 % Topical Cloth	SY	0029ecd1-a700-46a5-a5f9-c416fb2bb4f0	3
797544	isopropyl alcohol 70 % Topical Swab	SY	0029ecd1-a700-46a5-a5f9-c416fb2bb4f0	3
1010844	lidocaine HCl 4 % per 5 ML Injection	SY	0029ecd1-a700-46a5-a5f9-c416fb2bb4f0	3
1012406	Marcaine 0.5 % Injectable Solution	SY	0029ecd1-a700-46a5-a5f9-c416fb2bb4f0	3
1012406	Marcaine 5 MG/ML Injectable Solution	SY	0029ecd1-a700-46a5-a5f9-c416fb2bb4f0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70529-018-01	70529001801	1 KIT in 1 PACKAGE (70529-018-01) * 50 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET * 5 mL in 1 AMPULE	1 kit	2017-03-01	0000-00-00	No	No	Current