Doxy 100

Product NDC: 63323-130
11-digit product format: 633230130
Labeler code: 63323
Product ID: 63323-130_22ec807c-14e3-4b73-baa8-931ade7d3203
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DOXYCYCLINE
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA062475
Marketing category: ANDA
Marketing start: 2000-10-17
Substance: DOXYCYCLINE HYCLATE
Active strength: 100 mg/10mL
Pharmacologic classes: Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A062475-001	DOXY 100	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09
A062475-002	DOXY 200	DOXYCYCLINE HYCLATE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062475-001	AP
A062475-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`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	A062475-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062475-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062475-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062475-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062475-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062475-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062475-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062475-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062475-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062475-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062475-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062475-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062475-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062475-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062475-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062475-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062475-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062475-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062475-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062475-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062475-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062475-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062475-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062475-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062475-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062475-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062475-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062475-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062475-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062475-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062475-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062475-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062475-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062475-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062475-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062475-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062475-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062475-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062475-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062475-002	AP	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Doxy 100
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYCYCLINE HYCLATE	100 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
19XTS3T51U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310027	Internal RxNorm lookup
544840	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
b0894010-39bd-459f-8563-cf83343105ee	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b4321c75-2e87-4d90-9726-9a28fb2293a3	Product name	3	20260112
5e99724e-0654-4aec-b7a2-0b9b10e312ee	Product name	3	20250227
d2d36660-68ce-7e7d-0630-ec4b0d859fad	Product name	6	20220921
a239f4dd-cf93-4660-b190-f97d000f249f	Product name	7	20210607
a9d03566-caeb-4466-8021-74599b048880	Product name	3	20210604
12750814-20f7-4f35-b5fa-dbc8811ba858	Product name	9	20201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5ade	Product name	1	20200706
7b4b06ac-8c50-45f0-9556-293ea558a294	Product name	1	20180808
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84	Product name	5	20171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371	Product name	2	20171115
58b1278c-6dce-49b6-a05e-ea16f389acba	Product name	1	20160620

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-130-02	Doxy 100	10 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	10	8
63323-130-11	Doxy 100	10 in 1 TRAY	INJECTION, POWDER, LYOPHILIZED,	10	8
63323-130-03	Doxy 100	10 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	10	5
63323-130-13	Doxy 100	10 in 1 TRAY	INJECTION, POWDER, LYOPHILIZED,	10	5
63323-130-17	Doxy 100	10 in 1 TRAY	INJECTION, POWDER, LYOPHILIZED,	10	3
63323-130-41	Doxy 100	10 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	10	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-130-02	EA - Each	63323-130	edc7cbba-452b-471d-8d2b-4a2a363804bd	1	2021-08-05
63323-130-03	EA - Each	63323-130	a20d17a4-29c2-4d0e-9ea1-581bd979c321	1	2021-09-07
63323-130-11	EA - Each	63323-130	48113d52-439a-4a9f-b934-26c54770a14a	1	2013-02-13
63323-130-13	EA - Each	63323-130	7698ad16-4f9a-4a8a-a05b-b70c7a026c53	1	2013-09-04
63323-130-17	EA - Each	63323-130	9f82722c-19ff-46b8-9323-dabe43b13861	1	2014-12-01
63323-130-41	EA - Each	63323-130	8403a847-92ed-40b5-ad20-d703f943c9e2	1	2022-01-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXYCYCLINE HYCLATE	ACTIVE INGREDIENT	19XTS3T51U	DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	4
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	4
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	4
DOXYCYCLINE HYCLATE	ACTIVE INGREDIENT	19XTS3T51U	DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	2
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	2
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	2
Doxycycline Hyclate	ACTIVE INGREDIENT	19XTS3T51U	DOXY 100 (DOXYCYCLINE HYCLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
DOXYCYCLINE HYCLATE	ACTIVE INGREDIENT	19XTS3T51U	DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
Doxycycline Anhydrous	ACTIVE MOIETY	334895S862	DOXY 100 (DOXYCYCLINE HYCLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-130	DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	8	Current NDC, Legacy NDC, 2 package rows	20200610_b0894010-39bd-459f-8563-cf83343105ee.zip
63323-130	DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]	5	Current NDC, Legacy NDC, 2 package rows	20210312_b256babb-1bba-4b0c-8837-d13ba3af7659.zip
63323-130	DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]	3	Current NDC, Legacy NDC, 2 package rows	20210204_a7b754e2-a028-469d-ba95-8412ef03ab0a.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXY 100(TM) DOXYCYCLINE	DOXY 100(TM) DOXYCYCLINE	HF Acquisition Co LLC, DBA HealthFirst	9454f948-584f-59de-e053-2a95a90a9f01	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062475 application number: ANDA062475
Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	b256babb-1bba-4b0c-8837-d13ba3af7659	2021-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062475 application number: ANDA062475 ndc (product): 63323-130
Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	a7b754e2-a028-469d-ba95-8412ef03ab0a	2021-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062475 application number: ANDA062475 ndc (product): 63323-130
Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	b0894010-39bd-459f-8563-cf83343105ee	2020-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062475 application number: ANDA062475 ndc (product): 63323-130

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19XTS3T51U	DOXYCYCLINE HYCLATE	24390-14-5	DOXYCYCLINE HYCLATE
N12000U13O	DOXYCYCLINE	17086-28-1	DOXYCYCLINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
544840	Doxy 100, 100 MG Injection	PSN	b0894010-39bd-459f-8563-cf83343105ee	8
310027	doxycycline hyclate 100 MG Injection	PSN	b0894010-39bd-459f-8563-cf83343105ee	8
544840	doxycycline hyclate 100 MG Injection [Doxy]	SBD	b0894010-39bd-459f-8563-cf83343105ee	8
310027	doxycycline hyclate 100 MG Injection	SCD	b0894010-39bd-459f-8563-cf83343105ee	8
544840	Doxy 10 MG/ML Injectable Solution	SY	b0894010-39bd-459f-8563-cf83343105ee	8
544840	Doxy 100, 10 MG/ML Injectable Solution	SY	b0894010-39bd-459f-8563-cf83343105ee	8
544840	Doxy 100, 100 MG Injection	SY	b0894010-39bd-459f-8563-cf83343105ee	8
544840	Doxy 100, 100 MG per 10 ML Injectable Solution	SY	b0894010-39bd-459f-8563-cf83343105ee	8
544840	Doxy 100, 100 MG Injection	PSN	b256babb-1bba-4b0c-8837-d13ba3af7659	5
310027	doxycycline hyclate 100 MG Injection	PSN	b256babb-1bba-4b0c-8837-d13ba3af7659	5
544840	doxycycline hyclate 100 MG Injection [Doxy]	SBD	b256babb-1bba-4b0c-8837-d13ba3af7659	5
310027	doxycycline hyclate 100 MG Injection	SCD	b256babb-1bba-4b0c-8837-d13ba3af7659	5
544840	Doxy 10 MG/ML Injectable Solution	SY	b256babb-1bba-4b0c-8837-d13ba3af7659	5
544840	Doxy 100, 10 MG/ML Injectable Solution	SY	b256babb-1bba-4b0c-8837-d13ba3af7659	5
544840	Doxy 100, 100 MG Injection	SY	b256babb-1bba-4b0c-8837-d13ba3af7659	5
544840	Doxy 100, 100 MG per 10 ML Injectable Solution	SY	b256babb-1bba-4b0c-8837-d13ba3af7659	5
310027	doxycycline hyclate 100 MG Injection	PSN	9454f948-584f-59de-e053-2a95a90a9f01	4
310027	doxycycline hyclate 100 MG Injection	SCD	9454f948-584f-59de-e053-2a95a90a9f01	4
544840	Doxy 100, 100 MG Injection	PSN	a7b754e2-a028-469d-ba95-8412ef03ab0a	3
310027	doxycycline hyclate 100 MG Injection	PSN	a7b754e2-a028-469d-ba95-8412ef03ab0a	3
544840	doxycycline hyclate 100 MG Injection [Doxy]	SBD	a7b754e2-a028-469d-ba95-8412ef03ab0a	3
310027	doxycycline hyclate 100 MG Injection	SCD	a7b754e2-a028-469d-ba95-8412ef03ab0a	3
544840	Doxy 10 MG/ML Injectable Solution	SY	a7b754e2-a028-469d-ba95-8412ef03ab0a	3
544840	Doxy 100, 10 MG/ML Injectable Solution	SY	a7b754e2-a028-469d-ba95-8412ef03ab0a	3
544840	Doxy 100, 100 MG Injection	SY	a7b754e2-a028-469d-ba95-8412ef03ab0a	3
544840	Doxy 100, 100 MG per 10 ML Injectable Solution	SY	a7b754e2-a028-469d-ba95-8412ef03ab0a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-130-02	63323013002	10 mL in 1 VIAL	10 ml					Historical
63323-130-03	63323013003	10 mL in 1 VIAL	10 ml					Historical
63323-130-11	63323013011	10 VIAL in 1 TRAY (63323-130-11) / 10 mL in 1 VIAL (63323-130-02)	10 vial	2000-10-17	0000-00-00	No	No	Current
63323-130-13	63323013013	10 VIAL in 1 TRAY (63323-130-13) / 10 mL in 1 VIAL (63323-130-03)	10 vial	2000-10-17	0000-00-00	No	No	Current
63323-130-17	63323013017	10 VIAL in 1 TRAY (63323-130-17) / 10 mL in 1 VIAL (63323-130-41)	10 vial	2000-10-17	0000-00-00	No	No	Current
63323-130-41	63323013041	10 mL in 1 VIAL	10 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOXY 100(TM) DOXYCYCLINE FOR INJECTION, USP 100mg per VIAL 20mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2024-01-30	HUMAN PRESCRIPTION DRUG LABEL	4
DOXY 100™	Fresenius Kabi USA, LLC	2021-02-17	HUMAN PRESCRIPTION DRUG LABEL	5
DOXY 100™	Fresenius Kabi USA, LLC	2021-02-02	HUMAN PRESCRIPTION DRUG LABEL	3
DOXY 100™ Doxycycline for Injection, USP	Fresenius Kabi USA, LLC	2020-06-04	HUMAN PRESCRIPTION DRUG LABEL	8
Doxy 100 Doxycycline for Injection, USP 100mg SDV	General Injectables & Vaccines, Inc	2020-02-21	HUMAN PRESCRIPTION DRUG LABEL	6