Cefditoren Pivoxil

Product NDC: 44009-802
11-digit product format: 440090802
Labeler code: 44009
Product ID: 44009-802_edeaf75d-92f5-4fef-a127-ad200561aa71
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cefditoren pivoxil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Pharma RomLev Inc.
Application: NDA021222
Marketing category: NDA
Marketing start: 2010-01-01
Marketing end: 0000-00-00
Substance: CEFDITOREN PIVOXIL
Active strength: 400 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	44009-802		I	Inactivated by FDA	2026-08-11
excluded package	package	44009-802	44009-802-20	I	Inactivated by FDA	2026-08-11
excluded package	package	44009-802	44009-802-28	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 2 · 66 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	44009-802-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	44009-802-20	`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	44009-802-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	44009-802-20	`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	44009-802-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	44009-802-20	`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	44009-802-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	44009-802-20	`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	44009-802-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	44009-802-20	`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	44009-802-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	44009-802-20	`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	44009-802-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	44009-802-20	`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	44009-802-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	44009-802-20	`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	44009-802-28	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	44009-802-20	`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	44009-802-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	44009-802-20	`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	44009-802-28	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	44009-802-20	`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	44009-802-28	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	44009-802-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	44009-802-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	44009-802-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	44009-802-28	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	44009-802-20	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	44009-802-28	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	44009-802-20	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	44009-802-28	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	44009-802-20	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	44009-802-28	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	44009-802-20	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	44009-802-28	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	44009-802-20	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	44009-802-28	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	44009-802-20	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	44009-802-28	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	44009-802-20	`e2bbac7714bc…`	`27bdfed8d636…`

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
N021222-001	SPECTRACEF	CEFDITOREN PIVOXIL	200MG	TABLET / ORAL			2001-08-29
N021222-002	SPECTRACEF	CEFDITOREN PIVOXIL	400MG	TABLET / ORAL			2008-07-21

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021222-001	SPECTRACEF	200MG	TABLET / ORAL	2001-08-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021222-002	SPECTRACEF	400MG	TABLET / ORAL	2008-07-21	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
735c6807-7b6d-31b0-8032-5eb0f5889757	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
44009-802-20	2019-11-27	C162847	48780-1	9855d018-e114-cd31-e053-dbdaa90ab51a	Cefditoren Pivoxil Tablets 200 mg and 400 mg
44009-802-28	2019-11-27	C162847	48780-1	9855d018-e114-cd31-e053-dbdaa90ab51a	Cefditoren Pivoxil Tablets 200 mg and 400 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44009-802-20	Cefditoren Pivoxil	20 in 1 BLISTER PACK	TABLET, FILM COATED	20		2
44009-802-28	Cefditoren Pivoxil	28 in 1 BLISTER PACK	TABLET, FILM COATED	28		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44009-802-20	EA - Each	44009-802	edfd666f-0440-49eb-b98c-3ebfcd61bbf6	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFDITOREN PIVOXIL	ACTIVE INGREDIENT	78THA212DH	CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]	2
CEFDITOREN	ACTIVE MOIETY	81QS09V3YW	CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]	2
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]	2
SODIUM CASEINATE	INACTIVE INGREDIENT	7473P66J9E	CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]	2
SODIUM TRIPOLYPHOSPHATE	INACTIVE INGREDIENT	5HK03SA80J	CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44009-802	CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.]	2	Legacy NDC, 2 package rows	20130606_d5050d0e-81d1-4707-a38a-e80de2aebf09.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
78THA212DH	CEFDITOREN PIVOXIL	117467-28-4	CEFDITOREN PIVOXIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351127	cefditoren pivoxil 200 MG Oral Tablet	PSN	d5050d0e-81d1-4707-a38a-e80de2aebf09	2
847360	cefditoren pivoxil 400 MG Oral Tablet	PSN	d5050d0e-81d1-4707-a38a-e80de2aebf09	2
351127	cefditoren pivoxil 200 MG Oral Tablet	SCD	d5050d0e-81d1-4707-a38a-e80de2aebf09	2
847360	cefditoren pivoxil 400 MG Oral Tablet	SCD	d5050d0e-81d1-4707-a38a-e80de2aebf09	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
44009-802-20	44009080220	20 in 1 BLISTER PACK	Historical
44009-802-28	44009080228	28 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefditoren Pivoxil Tablets 200 mg and 400 mg	Pharma RomLev Inc.	2013-06-04	HUMAN PRESCRIPTION DRUG LABEL	2