Doxycycline

Product NDC: 62332-250
11-digit product format: 623320250
Labeler code: 62332
Product ID: 62332-250_98baf50f-2355-4be4-a271-056988ea79fb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline
Dosage form: CAPSULE
Route: ORAL
Labeler: Alembic Pharmaceuticals Inc.
Application: ANDA209165
Marketing category: ANDA
Marketing start: 2017-07-31
Substance: DOXYCYCLINE
Active strength: 100 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209165-001	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2017-07-28
A209165-002	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2017-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209165-001	AB
A209165-002	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.

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`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	A209165-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209165-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209165-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209165-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209165-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209165-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209165-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209165-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209165-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209165-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209165-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209165-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209165-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209165-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209165-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209165-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209165-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209165-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209165-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209165-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209165-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209165-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209165-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209165-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209165-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209165-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209165-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209165-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209165-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209165-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209165-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209165-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209165-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209165-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209165-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209165-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209165-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209165-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209165-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209165-002	AB	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE	Proficient Rx LP	d9388b32-dcb8-4dff-8a35-8fccb31bd1f8	2026-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209165 application number: ANDA209165
Doxycycline	DOXYCYCLINE	Alembic Pharmaceuticals Inc.	d77e2a9c-c536-4e66-b87a-40b085737699	2025-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209165 application number: ANDA209165 ndc (product): 62332-250
Doxycycline	DOXYCYCLINE	NuCare Pharmaceuticals,Inc.	2a07049d-3950-d293-e063-6294a90a4450	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209165 application number: ANDA209165
Doxycycline	DOXYCYCLINE	Alembic Pharmaceuticals Limited	3dfa486c-4665-4882-93ac-9259708f899c	2023-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209165 application number: ANDA209165

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYCYCLINE	100 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
700408	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
d77e2a9c-c536-4e66-b87a-40b085737699	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
62332-250-30	Doxycycline	30 in 1 BOTTLE	CAPSULE	30	15
62332-250-50	Doxycycline	50 in 1 BOTTLE	CAPSULE	50	15
62332-250-60	Doxycycline	60 in 1 BOTTLE	CAPSULE	60	15
62332-250-61	Doxycycline	250 in 1 BOTTLE	CAPSULE	250	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62332-250-50	EA - Each	62332-250	09b1d40f-4dc5-4c88-8553-e42e5d4a653d	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62332-250	DOXYCYCLINE CAPSULE [ALEMBIC PHARMACEUTICALS INC.]	15	Current NDC, Legacy NDC, 4 package rows	20250424_d77e2a9c-c536-4e66-b87a-40b085737699.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	d77e2a9c-c536-4e66-b87a-40b085737699	15
700408	doxycycline monohydrate 75 MG Oral Capsule	PSN	d77e2a9c-c536-4e66-b87a-40b085737699	15
1649990	doxycycline monohydrate 100 MG Oral Capsule	SCD	d77e2a9c-c536-4e66-b87a-40b085737699	15
700408	doxycycline monohydrate 75 MG Oral Capsule	SCD	d77e2a9c-c536-4e66-b87a-40b085737699	15
1649990	doxycycline monohydrate 100 MG Oral Capsule	PSN	68187cd7-79f5-17b0-e053-2a91aa0a05f1	4
1649990	doxycycline monohydrate 100 MG Oral Capsule	SCD	68187cd7-79f5-17b0-e053-2a91aa0a05f1	4
1649990	doxycycline monohydrate 100 MG Oral Capsule	PSN	2a07049d-3950-d293-e063-6294a90a4450	2
1649990	doxycycline monohydrate 100 MG Oral Capsule	PSN	d9388b32-dcb8-4dff-8a35-8fccb31bd1f8	2
1649990	doxycycline monohydrate 100 MG Oral Capsule	SCD	2a07049d-3950-d293-e063-6294a90a4450	2
1649990	doxycycline monohydrate 100 MG Oral Capsule	SCD	d9388b32-dcb8-4dff-8a35-8fccb31bd1f8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62332-250-30	62332025030	30 CAPSULE in 1 BOTTLE (62332-250-30)	30 capsule	2017-07-31	0000-00-00	No	No	Current
62332-250-50	62332025050	50 CAPSULE in 1 BOTTLE (62332-250-50)	50 capsule	2017-07-31	0000-00-00	No	No	Current
62332-250-60	62332025060	60 CAPSULE in 1 BOTTLE (62332-250-60)	60 capsule	2017-07-31	0000-00-00	No	No	Current
62332-250-61	62332025061	250 CAPSULE in 1 BOTTLE (62332-250-61)	250 capsule	2017-07-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline Capsules, USP Rx only	Proficient Rx LP	2026-03-01	HUMAN PRESCRIPTION DRUG LABEL	2
Doxycycline Capsules, USP Rx only	Alembic Pharmaceuticals Inc. \| Alembic Pharmaceuticals Limited	2025-04-14	Human Prescription Drug Label	15
Doxycycline Capsules, USP Rx only	NuCare Pharmaceuticals,Inc.	2024-12-24	HUMAN PRESCRIPTION DRUG LABEL	2
doxycycline	RedPharm Drug, Inc.	2022-01-21	HUMAN PRESCRIPTION DRUG LABEL	4