Doxycycline

Product NDC
70518-0221
11-digit product format
705180221
Labeler code
70518
Product ID
70518-0221_9fda45b7-c59f-a481-e053-2995a90ab785
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065055
Marketing category
ANDA
Marketing start
2017-02-14
Marketing end
0000-00-00
Substance
DOXYCYCLINE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-0221DDiscontinued by firm2026-08-03
excluded packagepackage70518-022170518-0221-0DDiscontinued by firm2026-08-03
excluded packagepackage70518-022170518-0221-1DDiscontinued by firm2026-08-03
excluded packagepackage70518-022170518-0221-2DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065055-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01
A065055-002DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01
A065055-003DOXYCYCLINEDOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15
A065055-004DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065055-001AB
A065055-002AB
A065055-003AB

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 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-02-18 07:12 UTC2024-02A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-011c564ffb4f44…
2024-02-18 07:12 UTC2024-02A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-011c564ffb4f44…
2024-02-18 07:12 UTC2024-02A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-151c564ffb4f44…
2024-02-18 07:12 UTC2024-02A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-019b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-019b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-159b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-013f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-013f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-153f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01053a50430f4f…
2023-05-13 08:27 UTC2023-05A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01053a50430f4f…
2023-05-13 08:27 UTC2023-05A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15053a50430f4f…
2023-05-13 08:27 UTC2023-05A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-013bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-013bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-153bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-013a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-013a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-153a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-02-18 07:12 UTC2024-02A065055-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A065055-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A065055-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065055-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A065055-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A065055-003AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065055-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065055-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065055-003AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065055-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065055-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065055-003AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065055-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065055-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065055-003AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065055-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065055-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065055-003AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065055-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A065055-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A065055-003AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065055-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A065055-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A065055-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065055-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065055-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065055-003AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065055-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A065055-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A065055-003AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065055-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A065055-002AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A065055-003AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065055-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065055-002AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065055-003AB1cb3db0bc1861…
2026-08-01 22:54:322026-06A065055-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A065055-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A065055-003AB1a50c72e98297…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINEBryant Ranch Prepack04de98f3-33a2-48ba-85b5-9fac867524b72026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEGolden State Medical Supply, Inc.e9997efa-9ad8-3870-e053-2a95a90a1ac32026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEStrides Pharma Science Limited9e710113-f25e-46fb-8327-7a8e649613a22026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEAmerican Health Packaginge49f8ff9-af7a-47eb-929b-238cff381c032026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEAmerican Health Packaging3fbf4bb8-036e-41d3-9628-476fc05ddd312026-02-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEBryant Ranch Prepack6285181d-e34d-4def-abe6-2c41254ada752026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEStrides Pharma Science Limitedd27c58a1-5c99-4007-9bc6-ad9b6fb56db82025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINENuCare Pharmaceuticals,Inc.fa1da527-7a0f-8ed6-e053-6394a90a1b622024-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEProficient Rx LPc707566b-dbc7-4dac-bad1-952f2f4d68452024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEA-S Medication Solutions6aab6fee-791e-4141-b55f-685ec9d8712a2023-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055