doxycycline hyclate

Product NDC: 62135-985
11-digit product format: 621350985
Labeler code: 62135
Product ID: 62135-985_40077986-5ebb-f8f0-e063-6394a90ad09f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxycycline hyclate
Dosage form: CAPSULE
Route: ORAL
Labeler: Chartwell RX LLC
Application: ANDA062500
Marketing category: ANDA
Marketing start: 1984-09-11
Substance: DOXYCYCLINE HYCLATE
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
A062500-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-09-11
A062500-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062500-001	AB
A062500-002	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	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062500-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1984-09-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062500-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1984-09-11	`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	A062500-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062500-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062500-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062500-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062500-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062500-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062500-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062500-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062500-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062500-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062500-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062500-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062500-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062500-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062500-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062500-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062500-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062500-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062500-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062500-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062500-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062500-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062500-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062500-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062500-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062500-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062500-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062500-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062500-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062500-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062500-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062500-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062500-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062500-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062500-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062500-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062500-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062500-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062500-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062500-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYCYCLINE HYCLATE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
19XTS3T51U	Internal UNII lookup
N12000U13O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1649405	Internal RxNorm lookup
1649988	Internal RxNorm lookup
1650030	Internal RxNorm lookup
1650143	Internal RxNorm lookup
1652674	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
3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35	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
62135-985-01	doxycycline hyclate	100 in 1 BOTTLE	CAPSULE	100	16
62135-985-05	doxycycline hyclate	500 in 1 BOTTLE	CAPSULE	500	16
62135-985-10	doxycycline hyclate	1000 in 1 BOTTLE	CAPSULE	1000	16
62135-985-50	doxycycline hyclate	50 in 1 BOTTLE	CAPSULE	50	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-985-05	EA - Each	62135-985	fcd45a64-61cb-4f0e-88eb-79efd402577c	1	2019-07-02
62135-985-50	EA - Each	62135-985	f9b4c21a-fb0e-4422-bf3f-7fa89aa44f0d	1	2019-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Doxycycline Hyclate	ACTIVE INGREDIENT	19XTS3T51U	DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]	3
Doxycycline Anhydrous	ACTIVE MOIETY	334895S862	DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]	3
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]	3
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]	3
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]	3
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]	3
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]	3
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]	3
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]	3
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]	3
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]	3
DOXYCYCLINE HYCLATE	ACTIVE INGREDIENT	19XTS3T51U	DOXYCYCLINE HYCLATE CAPSULE [CHARTWELL RX LLC]	1
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	DOXYCYCLINE HYCLATE CAPSULE [CHARTWELL RX LLC]	1
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	DOXYCYCLINE HYCLATE CAPSULE [CHARTWELL RX LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DOXYCYCLINE HYCLATE CAPSULE [CHARTWELL RX LLC]	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	DOXYCYCLINE HYCLATE CAPSULE [CHARTWELL RX LLC]	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	DOXYCYCLINE HYCLATE CAPSULE [CHARTWELL RX LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DOXYCYCLINE HYCLATE CAPSULE [CHARTWELL RX LLC]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DOXYCYCLINE HYCLATE CAPSULE [CHARTWELL RX LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DOXYCYCLINE HYCLATE CAPSULE [CHARTWELL RX LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DOXYCYCLINE HYCLATE CAPSULE [CHARTWELL RX LLC]	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	DOXYCYCLINE HYCLATE CAPSULE [CHARTWELL RX LLC]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DOXYCYCLINE HYCLATE CAPSULE [CHARTWELL RX LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-985	DOXYCYCLINE HYCLATE TABLET, FILM COATED DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE POWDER, FOR SUSPENSION [CHARTWELL RX LLC]	15	Current NDC, Legacy NDC, 4 package rows	20240402_3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
doxycycline hyclate	DOXYCYCLINE HYCLATE	HAWAII REPACK, INC	88c429a1-351d-432e-b69b-d7a0afca482a	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	0aaa4ff7-7fba-4a40-9b49-82e4da68a48f	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	Sportpharm LLC	50617adc-8528-414d-bb6c-78887d404983	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	6e06e73c-b777-4a2d-988f-b009f2fc34d1	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	6f530f28-8c10-41dc-818f-1aef2306bde5	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Health Department, Oklahoma State	f39365f9-eb64-00cb-e053-2995a90a8d80	2025-12-31	Warnings	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	6624a43a-28ff-4d55-b5dd-1e805bfa8778	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline	DOXYCYCLINE	Chartwell Governmental & Specialty RX, LLC	b8486639-7eb9-4610-9cd4-0e922045d592	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline	DOXYCYCLINE	Chartwell RX LLC	3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500 ndc (product): 62135-985
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Asclemed USA, Inc.	a5571acf-3284-4559-8cc0-b4856ac6d94d	2025-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	a5f02688-cbba-4d9b-e053-2995a90ad1ba	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	a2161675-505c-3d65-e053-2995a90aa644	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	a2df1a8c-7a22-462d-830a-04e6ac5a912f	2024-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	1dd7a94e-bf29-4f07-9476-ac8d1f9ab565	2024-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	4164f6b7-5ebd-4f5f-a536-9a37b2e0562c	2024-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	2993ac3d-0ec4-4230-858e-9fd00063cf57	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500
doxycycline hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	3303b423-b270-495b-9360-e43144fcf6f2	2021-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062500 application number: ANDA062500

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35	16
1650143	doxycycline hyclate 100 MG Oral Tablet	PSN	3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35	16
1649405	doxycycline hyclate 50 MG Oral Capsule	PSN	3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35	16
1652674	doxycycline hyclate 50 MG Oral Tablet	PSN	3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35	16
1650030	doxycycline monohydrate 25 MG in 5 mL Oral Suspension	PSN	3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35	16
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35	16
1650143	doxycycline hyclate 100 MG Oral Tablet	SCD	3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35	16
1649405	doxycycline hyclate 50 MG Oral Capsule	SCD	3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35	16
1652674	doxycycline hyclate 50 MG Oral Tablet	SCD	3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35	16
1650030	doxycycline monohydrate 5 MG/ML Oral Suspension	SCD	3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35	16
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35	16
1650030	doxycycline monohydrate 25 MG per 5 ML Oral Suspension	SY	3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35	16
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	1dd7a94e-bf29-4f07-9476-ac8d1f9ab565	8
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	1dd7a94e-bf29-4f07-9476-ac8d1f9ab565	8
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	1dd7a94e-bf29-4f07-9476-ac8d1f9ab565	8
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	4164f6b7-5ebd-4f5f-a536-9a37b2e0562c	7
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	6f530f28-8c10-41dc-818f-1aef2306bde5	7
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	4164f6b7-5ebd-4f5f-a536-9a37b2e0562c	7
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	6f530f28-8c10-41dc-818f-1aef2306bde5	7
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	4164f6b7-5ebd-4f5f-a536-9a37b2e0562c	7
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	6f530f28-8c10-41dc-818f-1aef2306bde5	7
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	a5f02688-cbba-4d9b-e053-2995a90ad1ba	4
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	f39365f9-eb64-00cb-e053-2995a90a8d80	4
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	a2161675-505c-3d65-e053-2995a90aa644	4
1650143	doxycycline hyclate 100 MG Oral Tablet	PSN	f39365f9-eb64-00cb-e053-2995a90a8d80	4
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	f39365f9-eb64-00cb-e053-2995a90a8d80	4
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	a2161675-505c-3d65-e053-2995a90aa644	4
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	a5f02688-cbba-4d9b-e053-2995a90ad1ba	4
1650143	doxycycline hyclate 100 MG Oral Tablet	SCD	f39365f9-eb64-00cb-e053-2995a90a8d80	4
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	a2161675-505c-3d65-e053-2995a90aa644	4
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	a5f02688-cbba-4d9b-e053-2995a90ad1ba	4
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	f39365f9-eb64-00cb-e053-2995a90a8d80	4
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	a5571acf-3284-4559-8cc0-b4856ac6d94d	3
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	a5571acf-3284-4559-8cc0-b4856ac6d94d	3
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	a5571acf-3284-4559-8cc0-b4856ac6d94d	3
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	2993ac3d-0ec4-4230-858e-9fd00063cf57	2
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	2993ac3d-0ec4-4230-858e-9fd00063cf57	2
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	2993ac3d-0ec4-4230-858e-9fd00063cf57	2
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	b429a1e9-5bbb-8b27-e053-2a95a90a089f	1
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	50617adc-8528-414d-bb6c-78887d404983	1
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	b429a1e9-5bbb-8b27-e053-2a95a90a089f	1
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	50617adc-8528-414d-bb6c-78887d404983	1
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	b429a1e9-5bbb-8b27-e053-2a95a90a089f	1
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	50617adc-8528-414d-bb6c-78887d404983	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62135-985-01	62135098501	100 CAPSULE in 1 BOTTLE (62135-985-01)	100 capsule	2020-09-01	0000-00-00	No	No	Current
62135-985-05	62135098505	500 CAPSULE in 1 BOTTLE (62135-985-05)	500 capsule	1984-09-11	0000-00-00	No	No	Current
62135-985-10	62135098510	1000 CAPSULE in 1 BOTTLE (62135-985-10)	1000 capsule	2020-09-01	0000-00-00	No	No	Current
62135-985-50	62135098550	50 CAPSULE in 1 BOTTLE (62135-985-50)	50 capsule	1984-09-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline Hyclate Capsules, USP	HAWAII REPACK, INC	2026-07-09	HUMAN PRESCRIPTION DRUG LABEL	1
Doxycycline Hyclate Capsules, USP	Sportpharm LLC	2026-02-05	HUMAN PRESCRIPTION DRUG LABEL	1
Doxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP	Bryant Ranch Prepack	2026-01-26	HUMAN PRESCRIPTION DRUG LABEL	7
Doxycycline Hyclate	Health Department, Oklahoma State	2025-12-31	HUMAN PRESCRIPTION DRUG LABEL	4
Doxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP	Chartwell RX LLC	2025-09-30	HUMAN PRESCRIPTION DRUG LABEL	16
Doxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP	REMEDYREPACK INC.	2025-07-29	HUMAN PRESCRIPTION DRUG LABEL	5
Doxycycline Hyclate Capsules, USP	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-05-31	HUMAN PRESCRIPTION DRUG LABEL	3
Doxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	4
Doxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP	NuCare Pharmaceuticals,Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	4
Doxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP	A-S Medication Solutions	2024-04-28	HUMAN PRESCRIPTION DRUG LABEL	8
Doxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP	A-S Medication Solutions	2024-04-28	HUMAN PRESCRIPTION DRUG LABEL	7
Doxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	2
Doxycycline Hyclate Capsule Rx only	AvKARE	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	2
Doxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP	ab2289a5-54dd-3b00-e053-2a95a90a0de4 \| Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2022-01-03	HUMAN PRESCRIPTION DRUG LABEL	3
Doxycycline Hyclate Capsules, USP	Medsource Pharmaceuticals	2020-11-15	HUMAN PRESCRIPTION DRUG LABEL	1
Doxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP	Chartwell RX LLC \| Chartwell Pharmaceuticals LLC	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	6