doxycycline

Product NDC: 65841-821
11-digit product format: 658410821
Labeler code: 65841
Product ID: 65841-821_d9de3252-a876-482e-be60-0a47eb985aa8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxycycline
Dosage form: CAPSULE
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA205115
Marketing category: ANDA
Marketing start: 2016-03-14
Substance: DOXYCYCLINE
Active strength: 50 mg/1
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205115-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18
A205115-002	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18
A205115-003	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A205115-001	AB
A205115-002	AB
A205115-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A205115-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205115-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205115-003	AB	1	`a50c72e98297…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
doxycycline	DOXYCYCLINE	PD-Rx Pharmaceuticals, Inc.	7028b7f9-21cd-4c8e-97aa-a3e7d849939b	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
doxycycline	DOXYCYCLINE	PD-Rx Pharmaceuticals, Inc.	dedebcb4-3c3f-4487-a488-36af12640c92	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
DOXYCYCLINE	DOXYCYCLINE	DIRECT RX	31512ece-cb16-2a9a-e054-00144ff88e88	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
doxycycline	DOXYCYCLINE	A-S Medication Solutions	2c7795c9-9e4e-477a-ad9f-01e4c55c06b6	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
doxycycline	DOXYCYCLINE	AvPAK	a5b28a41-db12-af7c-e053-2995a90ace09	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
doxycycline	DOXYCYCLINE	Zydus Pharmaceuticals USA Inc.	fef9580d-8850-4cbb-89eb-2b4d40ee59c9	2025-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
doxycycline	DOXYCYCLINE	Zydus Lifesciences Limited	aa01035d-8b4a-4fdc-bfdf-2b39df0d8fc9	2024-11-28		Exact identifier application applno (ANDA): 205115 application number: ANDA205115 ndc (product): 65841-821
doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	5f989cc1-48ae-41bb-b297-2f8c83760b6d	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
doxycycline	DOXYCYCLINE	Proficient Rx LP	f3ba6c30-ada3-4a57-9ff8-30558202b9aa	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYCYCLINE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
N12000U13O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
700408	Internal RxNorm lookup
1649401	Internal RxNorm lookup
1649990	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
aa01035d-8b4a-4fdc-bfdf-2b39df0d8fc9	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
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
65841-821-01	doxycycline	100 in 1 BOTTLE	CAPSULE	100	7
65841-821-05	doxycycline	500 in 1 BOTTLE	CAPSULE	500	7
65841-821-06	doxycycline	30 in 1 BOTTLE	CAPSULE	30	7
65841-821-10	doxycycline	1000 in 1 BOTTLE	CAPSULE	1000	7
65841-821-16	doxycycline	90 in 1 BOTTLE	CAPSULE	90	7
65841-821-18	doxycycline	50 in 1 BOTTLE	CAPSULE	50	7
65841-821-30	doxycycline	10 in 1 BLISTER PACK	CAPSULE	10	7
65841-821-77	doxycycline	10 in 1 CARTON	CAPSULE	10	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-821	DOXYCYCLINE CAPSULE [ZYDUS LIFESCIENCES LIMITED]	7	Current NDC, Legacy NDC, 8 package rows	20241201_aa01035d-8b4a-4fdc-bfdf-2b39df0d8fc9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N12000U13O	DOXYCYCLINE	17086-28-1	DOXYCYCLINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1649990	doxycycline monohydrate 100 MG Oral Capsule	PSN	aa01035d-8b4a-4fdc-bfdf-2b39df0d8fc9	7
1649401	doxycycline monohydrate 50 MG Oral Capsule	PSN	aa01035d-8b4a-4fdc-bfdf-2b39df0d8fc9	7
700408	doxycycline monohydrate 75 MG Oral Capsule	PSN	aa01035d-8b4a-4fdc-bfdf-2b39df0d8fc9	7
1649990	doxycycline monohydrate 100 MG Oral Capsule	SCD	aa01035d-8b4a-4fdc-bfdf-2b39df0d8fc9	7
1649401	doxycycline monohydrate 50 MG Oral Capsule	SCD	aa01035d-8b4a-4fdc-bfdf-2b39df0d8fc9	7
700408	doxycycline monohydrate 75 MG Oral Capsule	SCD	aa01035d-8b4a-4fdc-bfdf-2b39df0d8fc9	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65841-821-01	65841082101	100 CAPSULE in 1 BOTTLE (65841-821-01)	100 capsule	2016-03-14	0000-00-00	No	No	Current
65841-821-05	65841082105	500 CAPSULE in 1 BOTTLE (65841-821-05)	500 capsule	2016-03-14	0000-00-00	No	No	Current
65841-821-06	65841082106	30 CAPSULE in 1 BOTTLE (65841-821-06)	30 capsule	2016-03-14	0000-00-00	No	No	Current
65841-821-10	65841082110	1000 CAPSULE in 1 BOTTLE (65841-821-10)	1000 capsule	2016-03-14	0000-00-00	No	No	Current
65841-821-16	65841082116	90 CAPSULE in 1 BOTTLE (65841-821-16)	90 capsule	2016-03-14	0000-00-00	No	No	Current
65841-821-18	65841082118	50 CAPSULE in 1 BOTTLE (65841-821-18)	50 capsule	2016-03-14	0000-00-00	No	No	Current
65841-821-30	65841082130	10 in 1 BLISTER PACK						Historical
65841-821-77	65841082177	10 BLISTER PACK in 1 CARTON (65841-821-77) / 10 CAPSULE in 1 BLISTER PACK (65841-821-30)	10 blister pack	2016-03-14	0000-00-00	No	No	Current