DOXYCYCLINE

Product NDC: 70748-338
Requested package NDC: 70748-338-10
11-digit product format: 707480338
Labeler code: 70748
Product ID: 70748-338_8aa2cef1-9f23-46ed-bd30-d54812779f6b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxycycline
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA217794
Marketing category: ANDA
Marketing start: 2024-05-31
Substance: DOXYCYCLINE HYCLATE
Active strength: 100 mg/10mL
Pharmacologic classes: Tetracycline-class Drug [EPC], Tetracyclines [CS]
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 43.

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
A217794-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP		2024-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217794-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217794-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-03-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217794-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-03-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217794-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217794-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217794-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217794-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217794-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217794-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217794-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217794-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217794-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217794-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217794-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217794-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-03-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217794-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-03-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217794-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-03-14	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217794-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-03-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217794-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217794-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217794-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217794-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217794-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217794-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217794-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217794-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217794-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217794-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217794-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217794-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217794-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217794-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217794-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217794-001	AP	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217794-001	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310027	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
2946fc05-78e5-4669-85d1-3a3979eceae0	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70748-338-10	DOXYCYCLINE	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		10
70748-338-10	DOXYCYCLINE	10 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	10		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70748-338-10	EA - Each	70748-338	c252f71e-e00d-425f-abb4-6666995506b6	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70748-338	DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LUPIN PHARMACEUTICALS, INC.]	8	Current NDC, 2 package rows	20250302_2946fc05-78e5-4669-85d1-3a3979eceae0.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXYCYCLINE	DOXYCYCLINE	Lupin Pharmaceuticals, Inc.	2946fc05-78e5-4669-85d1-3a3979eceae0	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217794 application number: ANDA217794 ndc (package): 70748-338-10 ndc (product): 70748-338 ndc11 (package): 70748033810

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
310027	doxycycline hyclate 100 MG Injection	PSN	2946fc05-78e5-4669-85d1-3a3979eceae0	10
310027	doxycycline hyclate 100 MG Injection	SCD	2946fc05-78e5-4669-85d1-3a3979eceae0	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70748-338-10	70748033810	10 VIAL in 1 CARTON (70748-338-10) / 10 mL in 1 VIAL	10 vial	2024-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOXYCYCLINE FOR INJECTION, USP Rx Only	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2026-08-03	HUMAN PRESCRIPTION DRUG LABEL	11